Crohn's Disease
Conditions
Keywords
Crohn's Disease
Brief summary
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
Interventions
DRUGPlacebo
Oral Dosing
DRUGABT-494
Oral Dosing
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Crohn's disease (CD) for at least 90 days. 2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450. 3. Subject inadequately responded to or experienced intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).
Exclusion criteria
1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis. 2. Subject who has had surgical bowel resections in the past 6 months or is planning resection. 3. Subjects with an ostomy or ileoanal pouch. 4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess. 5. Subject who has short bowel syndrome. 6. Subject with recurring infections or active Tuberculosis (TB).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 | Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.) | Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. |
| Percentage of Participants Who Achieve Clinical Remission at Week 16 | Week 16 | Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Clinical Remission at Week 12 | Week 12 | Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Achieve Remission at Week 16 | Week 16 | Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants Who Achieve Response at Week 16 | Week 16 | Response is defined as endoscopic response at Week 12/16 AND clinical response at Week 16. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants With Endoscopic Response at Week 12/16 | Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.) | Endoscopic response: SES-CD at least 25% reduction from Baseline. Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants Who Achieve Clinical Response at Week 16 | Week 16 | Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16 | Week 16 | Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 | Week 16 | CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission. |
| Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 | Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.) | Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 | Week 16 | Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 | Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.) | Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Baseline, Week 4, Week 16 | — |
| Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16 | Baseline, Week 16 | — |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Baseline, Week 8, Week 16 | The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life. |
| Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 | Week 16 | Remission is defined as endoscopic remission AND clinical remission. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16 | Week 16 | CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission and a score above 450 indicates very severe disease. |
| Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16 | Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.) | Endoscopic remission: SES-CD ≤ 4 and at least two point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline | Week 16 | Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Change From Baseline in Abdominal Pain Rating Scale at Week 12 | Baseline, Week 12 | Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable). |
| Change From Baseline in Abdominal Pain Rating Scale at Week 16 | Baseline, Week 16 | Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable). |
| Percentage of Participants Who Achieve Remission at Week 52 | Week 52 | Remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. See definitions of responder and clinical responder in Outcome Measure 7 of this record. |
| Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Week 52 | Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Week 52 | Endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus induction baseline and no subscore \> 1 in any individual variable. Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than induction baseline AND average daily abdominal pain \<= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. |
| Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Week 20, Week 28, Week 36, Week 44, Week 52 | Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Week 20, Week 28, Week 36, Week 44, Week 52 | Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Week 20, Week 28, Week 36, Week 44, Week 52 | Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Week 20, Week 28, Week 36, Week 44, Week 52 | Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Achieve Response at Week 52 | Week 52 | Response at Week 52 was defined as both endoscopic response at Week 52 and clinical response at Week 52. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants With SES-CD ≤ 2 at Week 52 | Week 52 | SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. |
| Percentage of Participants With SES-CD = 0 at Week 52 | Week 52 | SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. |
| Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Week 52 | Endoscopic response was defined as SES-CD at least 25% reduction from Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. |
| Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Week 52 | Enhanced endoscopic response was defined as SES-CD reduction from Induction Baseline \> 50% (or for an Induction Baseline SES-CD of 4, at least a 2 point reduction from Induction Baseline). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. |
| Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Week 52 | Endoscopic Improvement: SES-CD reduction from Induction Baseline \> 50% or endoscopic remission. Endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus Induction Baseline and no subscore \> 1 in any individual variable. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. |
| Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Week 52 | Endoscopic healing was defined as SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore \>= 1 at Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. |
| Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Week 20, Week 28, Week 36, Week 44, Week 52 | Clinical response was defined as average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Week 20, Week 28, Week 36, Week 44, Week 52 | Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Week 20, Week 28, Week 36, Week 44, Week 52 | Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline or average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Week 20, Week 28, Week 36, Week 44, Week 52 | Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Week 20, Week 28, Week 36, Week 44, Week 52 | CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission. |
| Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Baseline, Week 52 | Steroid-free remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2 point reduction versus Induction Baseline and no subscore \> 1 in any individual variable. Clinical remission: Average daily stool frequency ≤ 1.5 and not worse than baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. |
| Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Week 20, Week 28, Week 36, Week 44, Week 52 | Steroid-free clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Week 20, Week 28, Week 36, Week 44, Week 52 | Steroid-free modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Baseline, Week 52 | Steroid-free endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus Induction Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Week 20, Week 28, Week 36, Week 44, Week 52 | CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission. |
| Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Week 20, Week 28, Week 36, Week 44, Week 52 | CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline. |
| Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Baseline, Week 28, Week 52 | — |
| Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Baseline, Week 20, Week 28, Week 36, Week 44, Week 52 | — |
| Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 | Week 16 | CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission. |
| Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Baseline, Week 52 | The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. A positive change represents an improvement in health-related quality of life. |
| Change From Induction Baseline in EQ-5D VAS at Week 52 | Baseline, Week 52 | The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively. A positive change represents an improvement in health-related quality of life. |
| Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | Baseline, Week 52 | Presented as percentage of participants with given number of EIMs at Baseline (BL) and Week (Wk) 52. EIMs of Crohn's disease included anemia, autoimmune hepatitis, axial arthropathy, bronchiectasis, chronic obstructive pulmonary disease, episcleritis, erythema nodosum, iritis, nephrolithiasis, oral aphthous ulcers, peripheral arthropathy, primary sclerosing cholangitis, pyoderma gangrenosum, Sweet's syndrome, uveitis, and venous thromboembolism. |
| Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Baseline, Week 52 | Remission at Week 52 is defined as endoscopic remission at Week 52 AND clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. |
| Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Week 52 | Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than induction baseline AND average daily abdominal pain \<= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). |
| Change From Induction Baseline in IBDQ at Week 52 | Baseline, Week 52 | The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function, and social function. Each subscale can be computed with total scores ranging from 10 to 70, 5 to 35, 12 to 84, and 5 to 35, respectively. |
| Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16 | Week 16 | CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Double-Blind Induction Phase: Placebo BID Placebo BID during the 16-week double-blind Induction Phase. | 37 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase. | 39 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase. | 37 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase. | 36 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase. | 36 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase. | 35 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Extension (Weeks 16-52) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 4 | 4 |
| Double-Blind Extension (Weeks 16-52) | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 2 | 8 | 10 |
| Double-Blind Extension (Weeks 16-52) | Requires Alternative Therapy | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Double-Blind Extension (Weeks 16-52) | Subject Noncompliance | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 |
| Double-Blind Extension (Weeks 16-52) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 1 |
| Double-Blind Induction (Weeks 1-16) | Adverse Event | 3 | 4 | 0 | 7 | 1 | 2 | 0 | 0 | 0 | 0 |
| Double-Blind Induction (Weeks 1-16) | Lack of Efficacy | 3 | 1 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 |
| Double-Blind Induction (Weeks 1-16) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double-Blind Induction (Weeks 1-16) | Other | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Double-Blind Induction (Weeks 1-16) | Requires alternative therapy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double-Blind Induction (Weeks 1-16) | Subject Non-Compliance | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Double-Blind Induction (Weeks 1-16) | Withdrawal by Subject | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Double-Blind Induction Phase: Placebo BID | Double-Blind Induction Phase: Upadacitinib 3 mg BID | Double-Blind Induction Phase: Upadacitinib 6 mg BID | Double Blind Induction Phase: Upadacitinib 12 mg BID | Double Blind Induction Phase: Upadacitinib 24 mg BID | Double Blind Induction Phase: Upadacitinib 24 mg QD | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 12.14 | 39.7 years STANDARD_DEVIATION 14.03 | 40.5 years STANDARD_DEVIATION 13.41 | 40.8 years STANDARD_DEVIATION 15.18 | 42.5 years STANDARD_DEVIATION 10.02 | 40.2 years STANDARD_DEVIATION 12.6 | 40.7 years STANDARD_DEVIATION 12.9 |
| Fecal Calprotectin | 1734.7 mcg/g STANDARD_DEVIATION 2444.07 | 1925.9 mcg/g STANDARD_DEVIATION 2804.07 | 2128.5 mcg/g STANDARD_DEVIATION 1978.73 | 2067.9 mcg/g STANDARD_DEVIATION 2250.97 | 2074.8 mcg/g STANDARD_DEVIATION 2324.15 | 1808.7 mcg/g STANDARD_DEVIATION 2548.11 | 1960.8 mcg/g STANDARD_DEVIATION 2371.86 |
| High-sensitivity C-reactive protein (hsCRP) | 20.8 mg/L STANDARD_DEVIATION 34.29 | 23.6 mg/L STANDARD_DEVIATION 51.43 | 17.9 mg/L STANDARD_DEVIATION 17.92 | 26.9 mg/L STANDARD_DEVIATION 28.86 | 17.1 mg/L STANDARD_DEVIATION 26.49 | 17.1 mg/L STANDARD_DEVIATION 20.83 | 20.6 mg/L STANDARD_DEVIATION 32.11 |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | 118.0 units on a scale STANDARD_DEVIATION 28.45 | 115.2 units on a scale STANDARD_DEVIATION 27.48 | 113.7 units on a scale STANDARD_DEVIATION 25.86 | 115.2 units on a scale STANDARD_DEVIATION 36.05 | 113.8 units on a scale STANDARD_DEVIATION 35.97 | 120.7 units on a scale STANDARD_DEVIATION 36.25 | 116.1 units on a scale STANDARD_DEVIATION 31.6 |
| Sex: Female, Male Female | 24 Participants | 19 Participants | 21 Participants | 17 Participants | 25 Participants | 19 Participants | 125 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 16 Participants | 19 Participants | 11 Participants | 16 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 36 | 0 / 36 | 0 / 35 | 0 / 60 | 0 / 23 | 0 / 59 | 0 / 36 | 0 / 33 | 0 / 27 |
| other Total, other adverse events | 25 / 37 | 32 / 39 | 27 / 37 | 23 / 36 | 28 / 36 | 25 / 35 | 31 / 60 | 9 / 23 | 35 / 59 | 14 / 36 | 8 / 33 | 17 / 27 |
| serious Total, serious adverse events | 2 / 37 | 5 / 39 | 2 / 37 | 10 / 36 | 3 / 36 | 7 / 35 | 18 / 60 | 2 / 23 | 5 / 59 | 5 / 36 | 11 / 33 | 4 / 27 |
Outcome results
Primary
Percentage of Participants Who Achieve Clinical Remission at Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission at Week 16 | 10.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 16 | 12.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 16 | 27.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 16 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 16 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Remission at Week 16 | 14.3 percentage of participants |
p-value: 0.7495% CI: [-12.3, 17.3]Cochran-Mantel-Haenszel
p-value: 0.08295% CI: [-2, 34.3]Cochran-Mantel-Haenszel
p-value: 0.95295% CI: [-14.1, 15]Cochran-Mantel-Haenszel
p-value: 0.20595% CI: [-6.1, 28.5]Cochran-Mantel-Haenszel
p-value: 0.60795% CI: [-11.5, 19.6]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable.
Time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Population: Modified intention to Treat (mITT) Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 | 10.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 | 8.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 | 8.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 | 14.3 percentage of participants |
p-value: 0.05695% CI: [-0.3, 20.1]Cochran-Mantel-Haenszel
p-value: 0.10895% CI: [-1.6, 16.4]Cochran-Mantel-Haenszel
p-value: 0.09995% CI: [-1.5, 16.8]Cochran-Mantel-Haenszel
p-value: 0.00495% CI: [6.8, 35.2]Cochran-Mantel-Haenszel
p-value: 0.02595% CI: [1.8, 25.5]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Abdominal Pain Rating Scale at Week 12
Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
Time frame: Baseline, Week 12
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an assessment at baseline and given time point. Non-responder imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Baseline in Abdominal Pain Rating Scale at Week 12 | -1.1 units on a scale | Standard Deviation 1.84 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 12 | -1.0 units on a scale | Standard Deviation 2.61 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 12 | -2.6 units on a scale | Standard Deviation 2.53 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 12 | -2.4 units on a scale | Standard Deviation 3.17 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 12 | -2.7 units on a scale | Standard Deviation 2.52 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Baseline in Abdominal Pain Rating Scale at Week 12 | -1.0 units on a scale | Standard Deviation 1.99 |
p-value: 0.41295% CI: [-0.62, 1.5]mixed-effect model repeated measure
p-value: 0.0195% CI: [-2.47, -0.34]mixed-effect model repeated measure
p-value: 0.08295% CI: [-2.13, 0.13]mixed-effect model repeated measure
p-value: 0.00495% CI: [-2.73, -0.52]mixed-effect model repeated measure
p-value: 0.76695% CI: [-0.93, 1.26]mixed-effect model repeated measure
Secondary
Change From Baseline in Abdominal Pain Rating Scale at Week 16
Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
Time frame: Baseline, Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an assessment at Baseline and given time point. Non-responder imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Baseline in Abdominal Pain Rating Scale at Week 16 | -0.9 units on a scale | Standard Deviation 2.27 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 16 | -1.7 units on a scale | Standard Deviation 3.02 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 16 | -2.8 units on a scale | Standard Deviation 2.77 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 16 | -1.7 units on a scale | Standard Deviation 2.86 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Baseline in Abdominal Pain Rating Scale at Week 16 | -2.3 units on a scale | Standard Deviation 2.42 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Baseline in Abdominal Pain Rating Scale at Week 16 | -1.4 units on a scale | Standard Deviation 2.15 |
p-value: 0.31495% CI: [-1.75, 0.56]mixed-effect model repeated measure
p-value: 0.00295% CI: [-3.01, -0.68]mixed-effect model repeated measure
p-value: 0.25595% CI: [-1.94, 0.52]mixed-effect model repeated measure
p-value: 0.02295% CI: [-2.61, -0.2]mixed-effect model repeated measure
p-value: 0.23995% CI: [-1.92, 0.48]mixed-effect model repeated measure
Secondary
Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase
Time frame: Baseline, Week 4, Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants with an assessment at Baseline and Week 16 and with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 4 | 83.7 μg/g | Standard Deviation 1024.11 |
| Double-Blind Induction Phase: Placebo BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 16 | -128.9 μg/g | Standard Deviation 373.53 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 4 | -310.3 μg/g | Standard Deviation 2415.43 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 16 | -534.5 μg/g | Standard Deviation 3279.19 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 4 | -436.9 μg/g | Standard Deviation 1505.75 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 16 | -429.4 μg/g | Standard Deviation 2505.21 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 4 | -915.7 μg/g | Standard Deviation 1600.31 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 16 | -475.1 μg/g | Standard Deviation 2668.93 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 4 | -876.2 μg/g | Standard Deviation 2240.93 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 16 | -828.7 μg/g | Standard Deviation 986.09 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 4 | -255.8 μg/g | Standard Deviation 2407.47 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase | Week 16 | -698.4 μg/g | Standard Deviation 2228.85 |
Comparison: Week 4p-value: 0.78895% CI: [-865.69, 657.87]mixed-effect model repeated measure
Comparison: Week 4p-value: 0.32595% CI: [-1092.83, 364.29]mixed-effect model repeated measure
p-value: 0.01595% CI: [-1672.78, -179.63]mixed-effect model repeated measure
Comparison: Week 4p-value: 0.05395% CI: [-1534.52, 8.39]mixed-effect model repeated measure
Comparison: Week 4p-value: 0.35295% CI: [-1119.52, 400.56]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.50395% CI: [-1565.39, 772.9]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.53795% CI: [-1531.04, 802.44]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.42595% CI: [-1677.87, 711.52]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.13495% CI: [-2373.24, 322.08]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.29395% CI: [-1833.82, 557.96]mixed-effect model repeated measure
Secondary
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16
Time frame: Baseline, Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants with an assessment at Baseline and Week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16 | -0.1 mg/L | Standard Deviation 11.96 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16 | -3.0 mg/L | Standard Deviation 19.6 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16 | -3.9 mg/L | Standard Deviation 19.47 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16 | -6.1 mg/L | Standard Deviation 27.02 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16 | -14.8 mg/L | Standard Deviation 26.38 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16 | -2.7 mg/L | Standard Deviation 13.74 |
p-value: 0.92195% CI: [-9.02, 9.97]mixed-effect model repeated measure
p-value: 0.7595% CI: [-11.19, 8.08]mixed-effect model repeated measure
p-value: 0.795% CI: [-11.7, 7.87]mixed-effect model repeated measure
p-value: 0.02495% CI: [-21.38, -1.51]mixed-effect model repeated measure
p-value: 0.84595% CI: [-10.72, 8.79]mixed-effect model repeated measure
Secondary
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life.
Time frame: Baseline, Week 8, Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants with an assessment at Baseline and Week 16 and with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 16 | 14.5 units on a scale | Standard Deviation 29.15 |
| Double-Blind Induction Phase: Placebo BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 8 | 16.6 units on a scale | Standard Deviation 25.38 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 16 | 24.6 units on a scale | Standard Deviation 42.98 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 8 | 18.9 units on a scale | Standard Deviation 40.35 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 16 | 41.8 units on a scale | Standard Deviation 47.02 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 8 | 34.6 units on a scale | Standard Deviation 36.22 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 16 | 32.1 units on a scale | Standard Deviation 38.57 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 8 | 24.9 units on a scale | Standard Deviation 30.95 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 8 | 39.7 units on a scale | Standard Deviation 40.76 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 16 | 44.4 units on a scale | Standard Deviation 40.05 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 8 | 23.3 units on a scale | Standard Deviation 30.34 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase | Week 16 | 22.5 units on a scale | Standard Deviation 27.82 |
Comparison: Week 8p-value: 0.8395% CI: [-13.6, 16.92]mixed-effect model repeated measure
Comparison: Week 8p-value: 0.02795% CI: [2.03, 33]mixed-effect model repeated measure
Comparison: Week 8p-value: 0.26395% CI: [-6.72, 24.47]mixed-effect model repeated measure
Comparison: Week 8p-value: 0.00895% CI: [5.68, 37.52]mixed-effect model repeated measure
Comparison: Week 8p-value: 0.26995% CI: [-6.88, 24.53]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.23195% CI: [-6.63, 27.25]mixed-effect model repeated measure
p-value: 0.00295% CI: [10.68, 45.15]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.05795% CI: [-0.51, 34.72]mixed-effect model repeated measure
Comparison: Week 16p-value: 0.00295% CI: [11.12, 46.56]mixed-effect model repeated measure
p-value: 0.16595% CI: [-5.12, 29.72]mixed-effect model repeated measure
Secondary
Change From Induction Baseline in EQ-5D VAS at Week 52
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively. A positive change represents an improvement in health-related quality of life.
Time frame: Baseline, Week 52
Population: Participants from ITT population with an assessment at given time point. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 12.3 units on a scale | Standard Deviation 24.79 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | 18.2 units on a scale | Standard Deviation 19.19 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | 3.7 units on a scale | Standard Deviation 21.79 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Responders | 12.9 units on a scale | Standard Deviation 14.65 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | 22.2 units on a scale | Standard Deviation 17.16 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Responders | 26.9 units on a scale | Standard Deviation 12.8 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 11.9 units on a scale | Standard Deviation 18.73 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | 5.0 units on a scale | Standard Deviation 7.07 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | 0.8 units on a scale | Standard Deviation 11.72 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Responders | 34.8 units on a scale | Standard Deviation 22.55 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | 36.1 units on a scale | Standard Deviation 26.19 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 13.9 units on a scale | Standard Deviation 27.81 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | -1.0 units on a scale | Standard Deviation 4.24 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 4.7 units on a scale | Standard Deviation 14.22 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | 8.1 units on a scale | Standard Deviation 17.95 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Responders | 5.0 units on a scale | Standard Deviation 17.8 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | 0.0 units on a scale | Standard Deviation 0 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | 15.6 units on a scale | Standard Deviation 15.63 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Responders | 5.0 units on a scale | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 12.2 units on a scale | Standard Deviation 16.01 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 17.5 units on a scale | Standard Deviation 16.58 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | 40.0 units on a scale | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | 10.0 units on a scale | Standard Deviation 8.66 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | 29.0 units on a scale | Standard Deviation 25.36 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 20.3 units on a scale | Standard Deviation 21.23 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | 11.7 units on a scale | Standard Deviation 16.07 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical responders | -15.0 units on a scale | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in EQ-5D VAS at Week 52 | Clinical non-responders | 7.5 units on a scale | Standard Deviation 10.61 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in EQ-5D VAS at Week 52 | Non-responders | 0.0 units on a scale | Standard Deviation 15 |
Comparison: Respondersp-value: 0.26395% CI: [-6.79, 24.16]ANCOVA
Comparison: Respondersp-value: 0.03195% CI: [1.47, 28.93]ANCOVA
Comparison: Respondersp-value: 0.13595% CI: [-27.93, 3.9]ANCOVA
Comparison: Non-respondersp-value: 0.45895% CI: [-10.61, 23.27]ANCOVA
Comparison: Non-respondersp-value: 0.73895% CI: [-9.59, 13.45]ANCOVA
Comparison: Non-respondersp-value: 0.41295% CI: [-18.32, 7.6]ANCOVA
Comparison: Clinical respondersp-value: 0.53495% CI: [-8.56, 16.36]ANCOVA
Comparison: Clinical respondersp-value: 0.05295% CI: [-0.1, 22.01]ANCOVA
Comparison: Clinical respondersp-value: 0.02795% CI: [-26.15, -1.63]ANCOVA
Comparison: Clinical non-respondersp-value: 0.92895% CI: [-24.02, 21.97]ANCOVA
Comparison: Clinical non-respondersp-value: 0.65895% CI: [-13.72, 8.77]ANCOVA
Comparison: Clinical non-respondersp-value: 0.60195% CI: [-16.96, 9.96]ANCOVA
Secondary
Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. A positive change represents an improvement in health-related quality of life.
Time frame: Baseline, Week 52
Population: Participants from ITT population with an assessment at given time point. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.1435 units on a scale | Standard Deviation 0.1461 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Responders | 0.1350 units on a scale | Standard Deviation 0.1473 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.0208 units on a scale | Standard Deviation 0.2231 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | -0.0577 units on a scale | Standard Deviation 0.2225 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Responders | 0.1673 units on a scale | Standard Deviation 0.109 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | 0.0455 units on a scale | Standard Deviation 0.0643 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.0697 units on a scale | Standard Deviation 0.2091 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.1334 units on a scale | Standard Deviation 0.174 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.1090 units on a scale | Standard Deviation 0.1791 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | 0.0330 units on a scale | Standard Deviation 0.0677 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Responders | 0.2274 units on a scale | Standard Deviation 0.1524 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.2306 units on a scale | Standard Deviation 0.184 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Responders | 0.0122 units on a scale | Standard Deviation 0.1276 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.0449 units on a scale | Standard Deviation 0.1008 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | -0.0079 units on a scale | Standard Deviation 0.0228 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.0587 units on a scale | Standard Deviation 0.1298 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | 0.0000 units on a scale | Standard Deviation 0 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Responders | 0.3260 units on a scale | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.1288 units on a scale | Standard Deviation 0.1674 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.2198 units on a scale | Standard Deviation 0.1615 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.1125 units on a scale | Standard Deviation 0.221 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.4325 units on a scale | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | 0.0058 units on a scale | Standard Deviation 0.0708 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | 0.1325 units on a scale | Standard Deviation 0.1148 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.1542 units on a scale | Standard Deviation 0.2377 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.1758 units on a scale | Standard Deviation 0.3559 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical non-responders | 0.1122 units on a scale | Standard Deviation 0.1587 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Clinical responders | 0.1316 units on a scale | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52 | Non-responders | 0.1187 units on a scale | Standard Deviation 0.1128 |
Comparison: Respondersp-value: 0.89395% CI: [-0.1299, 0.1136]ANCOVA
Comparison: Respondersp-value: 0.18295% CI: [-0.0334, 0.1705]ANCOVA
Comparison: Respondersp-value: 0.03695% CI: [-0.2552, -0.0093]ANCOVA
Comparison: Non-respondersp-value: 0.31695% CI: [-0.0749, 0.2286]ANCOVA
Comparison: Non-respondersp-value: 0.27795% CI: [-0.0471, 0.1617]ANCOVA
Comparison: Non-respondersp-value: 0.46795% CI: [-0.0741, 0.1597]ANCOVA
Comparison: Clinical respondersp-value: 0.46495% CI: [-0.1336, 0.0616]ANCOVA
Comparison: Clinical respondersp-value: 0.34595% CI: [-0.0444, 0.1252]ANCOVA
Comparison: Clinical respondersp-value: 0.07195% CI: [-0.1822, 0.0076]ANCOVA
Comparison: Clinical non-respondersp-value: 0.31795% CI: [-0.1109, 0.3326]ANCOVA
Comparison: Clinical non-respondersp-value: 0.12595% CI: [-0.0248, 0.1945]ANCOVA
Comparison: Clinical non-respondersp-value: 0.3995% CI: [-0.0745, 0.1864]ANCOVA
Secondary
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Time frame: Baseline, Week 28, Week 52
Population: Participants from ITT population with an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 28 | -153.4 mcg/g | Standard Deviation 2722.96 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 52 | 1.0 mcg/g | Standard Deviation 2457.22 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | -150.3 mcg/g | Standard Deviation 958.76 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | 3.7 mcg/g | Standard Deviation 766.69 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 52 | -51.9 mcg/g | Standard Deviation 2650.98 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | -220.2 mcg/g | Standard Deviation 514.97 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 28 | -226.2 mcg/g | Standard Deviation 2261.16 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | -87.2 mcg/g | Standard Deviation 1494.35 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | 88.3 mcg/g | Standard Deviation 1689.67 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | -148.3 mcg/g | Standard Deviation 1315.46 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | -30.7 mcg/g | Standard Deviation 32.65 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 52 | -239.3 mcg/g | Standard Deviation 1443.14 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | -30.7 mcg/g | Standard Deviation 32.65 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 28 | -532.0 mcg/g | Standard Deviation 519.42 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 28 | -424.5 mcg/g | Standard Deviation 1102.22 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 52 | -524.1 mcg/g | Standard Deviation 521.31 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 52 | -3047.5 mcg/g | Standard Deviation 2509.27 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 28 | -2878.6 mcg/g | Standard Deviation 2584.43 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | 213.3 mcg/g | Standard Deviation 802.34 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | -834.5 mcg/g | Standard Deviation 3011.51 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | -704.0 mcg/g | Standard Deviation 2801.08 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 28 | -2794.6 mcg/g | Standard Deviation 3018.26 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 52 | -2617.4 mcg/g | Standard Deviation 3232.04 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | 606.0 mcg/g | Standard Deviation 1133.7 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 52 | -2371.8 mcg/g | Standard Deviation 2786.97 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | -562.8 mcg/g | Standard Deviation 1738.58 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 52 | -1510.3 mcg/g | Standard Deviation 2773.9 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 28 | -3563.7 mcg/g | Standard Deviation 4747.26 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | 183.7 mcg/g | Standard Deviation 443.97 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | -850.2 mcg/g | Standard Deviation 1821.34 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 28 | -2099.3 mcg/g | Standard Deviation 3083.34 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | 183.7 mcg/g | Standard Deviation 443.97 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 28 | -65.0 mcg/g | Standard Deviation 316.06 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | 0.0 mcg/g | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | -16.5 mcg/g | Standard Deviation 304.33 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | 0.0 mcg/g | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 52 | -44.3 mcg/g | Standard Deviation 350.61 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | -8.3 mcg/g | Standard Deviation 344.29 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 28 | -194.0 mcg/g | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Responders, Week 52 | -44.0 mcg/g | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 52 | -694.0 mcg/g | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | -121.0 mcg/g | Standard Deviation 395.16 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | -121.0 mcg/g | Standard Deviation 395.16 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | 70.0 mcg/g | Standard Deviation 123.85 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 28 | -694.0 mcg/g | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | 70.0 mcg/g | Standard Deviation 123.85 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | -326.8 mcg/g | Standard Deviation 817.71 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | -434.0 mcg/g | Standard Deviation 1030.64 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 28 | 117.5 mcg/g | Standard Deviation 166.17 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | -771.0 mcg/g | Standard Deviation 1090.36 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | -985.5 mcg/g | Standard Deviation 1393.71 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical responders, Week 52 | 117.5 mcg/g | Standard Deviation 166.17 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 52 | 760.5 mcg/g | Standard Deviation 1075.51 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Clinical non-responders, Week 28 | 760.5 mcg/g | Standard Deviation 1075.51 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 52 | 760.5 mcg/g | Standard Deviation 1075.51 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase | Non-responders, Week 28 | 760.5 mcg/g | Standard Deviation 1075.51 |
Comparison: Responders, Week 28p-value: 0.35695% CI: [-2369.73, 878.37]ANCOVA
Comparison: Responders, Week 28p-value: 0.15895% CI: [-2698.52, 459.5]ANCOVA
Comparison: Responders, Week 28p-value: 0.32295% CI: [-3531.3, 1199.32]ANCOVA
Comparison: Responders, Week 52p-value: 0.28795% CI: [-2387.16, 730.75]ANCOVA
Comparison: Responders, Week 52p-value: 0.08895% CI: [-2772.59, 200.43]ANCOVA
Comparison: Responders, Week 52p-value: 0.61395% CI: [-2505.74, 1501.38]ANCOVA
Comparison: Non-responders, Week 28p-value: 0.60995% CI: [-823.64, 1390.49]ANCOVA
Comparison: Non-responders, Week 28p-value: 0.85595% CI: [-930.47, 774.16]ANCOVA
Comparison: Non-responders, Week 28p-value: 0.58495% CI: [-751.66, 1318.57]ANCOVA
Comparison: Non-responders, Week 52p-value: 0.62495% CI: [-1095.03, 1808.19]ANCOVA
Comparison: Non-responders, Week 52p-value: 0.80695% CI: [-1233.48, 963.25]ANCOVA
Comparison: Non-responders, Week 52p-value: 0.79395% CI: [-1229.59, 1602.06]ANCOVA
Comparison: Clinical responders, Week 28p-value: 0.56195% CI: [-1350.04, 740.44]ANCOVA
Comparison: Clinical responders, Week 28p-value: 0.02495% CI: [-2083.81, -154.11]ANCOVA
Comparison: Clinical responders, Week 28p-value: 0.15695% CI: [-1959.79, 321.21]ANCOVA
Comparison: Clinical responders, Week 52p-value: 0.5895% CI: [-1592.66, 899.45]ANCOVA
Comparison: Clinical responders, Week 52p-value: 0.02995% CI: [-2415.88, -135.92]ANCOVA
Comparison: Clinical responders, Week 52p-value: 0.43195% CI: [-1883.23, 813.5]ANCOVA
Comparison: Clinical non-responders, Week 28p-value: 0.96595% CI: [-1200.67, 1149.95]ANCOVA
Comparison: Clinical non-responders, Week 28p-value: 0.12395% CI: [-183.52, 1430.64]ANCOVA
Comparison: Clinical non-responders, Week 28p-value: 0.59195% CI: [-1031.23, 1767.6]ANCOVA
Comparison: Clinical non-responders, Week 52p-value: 0.64295% CI: [-648.22, 1032.68]ANCOVA
Comparison: Clinical non-responders, Week 52p-value: 0.09395% CI: [-81.37, 992.95]ANCOVA
Comparison: Clinical non-responders, Week 52p-value: 0.29695% CI: [-428.99, 1356.2]ANCOVA
Secondary
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Time frame: Baseline, Week 20, Week 28, Week 36, Week 44, Week 52
Population: Participants from ITT population with an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | -3.5 mg/L | Standard Deviation 18.87 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | -1.7 mg/L | Standard Deviation 8.94 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 36 | -1.8 mg/L | Standard Deviation 25.57 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | -2.2 mg/L | Standard Deviation 9.72 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | -2.2 mg/L | Standard Deviation 7.71 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | -1.9 mg/L | Standard Deviation 8.11 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | -0.7 mg/L | Standard Deviation 8.86 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 44 | -5.4 mg/L | Standard Deviation 22.95 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -7.1 mg/L | Standard Deviation 18.6 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 52 | -4.3 mg/L | Standard Deviation 22.68 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | -1.3 mg/L | Standard Deviation 7.82 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | -2.8 mg/L | Standard Deviation 18.91 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 20 | -9.5 mg/L | Standard Deviation 21.77 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | -1.2 mg/L | Standard Deviation 8.67 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | -1.9 mg/L | Standard Deviation 7.83 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | -3.0 mg/L | Standard Deviation 9.61 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | -0.8 mg/L | Standard Deviation 20.85 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 28 | -6.0 mg/L | Standard Deviation 22.53 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | -5.4 mg/L | Standard Deviation 19.26 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | -1.7 mg/L | Standard Deviation 10.51 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 36 | -7.2 mg/L | Standard Deviation 10.86 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | -0.5 mg/L | Standard Deviation 16.69 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | 2.8 mg/L | Standard Deviation 17.81 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | -2.0 mg/L | Standard Deviation 12.93 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -6.9 mg/L | Standard Deviation 10.8 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 20 | -9.4 mg/L | Standard Deviation 11.14 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | 0.4 mg/L | Standard Deviation 0.51 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 28 | -3.6 mg/L | Standard Deviation 16.12 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | 0.4 mg/L | Standard Deviation 0.51 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 44 | -8.5 mg/L | Standard Deviation 12.18 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | -0.6 mg/L | Standard Deviation 1.43 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 52 | -7.0 mg/L | Standard Deviation 12.66 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | -1.6 mg/L | Standard Deviation 8.24 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | 0.4 mg/L | Standard Deviation 0.51 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | 1.4 mg/L | Standard Deviation 2.83 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | -0.2 mg/L | Standard Deviation 5.92 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | 5.2 mg/L | Standard Deviation 15.34 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | -2.1 mg/L | Standard Deviation 18.36 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | 11.1 mg/L | Standard Deviation 33.68 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | 3.0 mg/L | Standard Deviation 31.54 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | -15.3 mg/L | Standard Deviation 32.75 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | -4.9 mg/L | Standard Deviation 8.36 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | -19.2 mg/L | Standard Deviation 30.13 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 28 | -21.8 mg/L | Standard Deviation 17.93 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | -13.9 mg/L | Standard Deviation 37.06 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | -2.2 mg/L | Standard Deviation 9.28 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | -3.4 mg/L | Standard Deviation 32.58 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | -6.4 mg/L | Standard Deviation 27.03 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | -4.1 mg/L | Standard Deviation 27.93 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | -7.3 mg/L | Standard Deviation 24.87 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | -2.3 mg/L | Standard Deviation 9.37 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 20 | -20.8 mg/L | Standard Deviation 19.78 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 44 | -21.5 mg/L | Standard Deviation 19.78 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -18.0 mg/L | Standard Deviation 29.2 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 52 | -20.4 mg/L | Standard Deviation 18.76 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | -0.6 mg/L | Standard Deviation 6.82 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 36 | -22.5 mg/L | Standard Deviation 18.01 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | -18.6 mg/L | Standard Deviation 28.62 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | -3.4 mg/L | Standard Deviation 8.04 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | -8.5 mg/L | Standard Deviation 25 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | -6.5 mg/L | Standard Deviation 20.14 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 20 | 4.1 mg/L | Standard Deviation 36.5 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 28 | 7.0 mg/L | Standard Deviation 35.65 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 36 | 5.6 mg/L | Standard Deviation 35.87 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 44 | 5.8 mg/L | Standard Deviation 35.77 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 52 | 6.2 mg/L | Standard Deviation 35.82 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | -8.0 mg/L | Standard Deviation 18.77 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | 0.8 mg/L | Standard Deviation 45.98 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | 0.9 mg/L | Standard Deviation 45.88 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | 1.3 mg/L | Standard Deviation 45.26 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -3.0 mg/L | Standard Deviation 31.35 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | 0.0 mg/L | Standard Deviation 32.17 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | 9.1 mg/L | Standard Deviation 56.33 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | 9.3 mg/L | Standard Deviation 56.18 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | 10.2 mg/L | Standard Deviation 55.66 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | -6.2 mg/L | Standard Deviation 15.35 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | -5.7 mg/L | Standard Deviation 15.26 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | -6.1 mg/L | Standard Deviation 13.28 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | -6.2 mg/L | Standard Deviation 13.15 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | -6.3 mg/L | Standard Deviation 11.71 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 44 | 10.6 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 36 | -4.0 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | 7.3 mg/L | Standard Deviation 12.63 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | 7.3 mg/L | Standard Deviation 12.63 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 20 | -3.1 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | 7.3 mg/L | Standard Deviation 12.63 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | 3.0 mg/L | Standard Deviation 9.51 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -3.8 mg/L | Standard Deviation 5.59 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | 2.2 mg/L | Standard Deviation 7.92 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | 4.7 mg/L | Standard Deviation 11.5 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | 3.3 mg/L | Standard Deviation 8.88 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | 0.3 mg/L | Standard Deviation 9.78 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | 2.7 mg/L | Standard Deviation 10.77 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | 0.1 mg/L | Standard Deviation 5.93 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | 0.3 mg/L | Standard Deviation 10.89 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | 10.9 mg/L | Standard Deviation 15.47 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | -4.0 mg/L | Standard Deviation 4.77 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | 7.3 mg/L | Standard Deviation 12.63 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 52 | 0.4 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Responders, Week 28 | -4.2 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | -0.7 mg/L | Standard Deviation 0.81 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -2.2 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | 0.0 mg/L | Standard Deviation 0.33 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | 0.4 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | -0.7 mg/L | Standard Deviation 0.95 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | -1.0 mg/L | Standard Deviation 0.97 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | -0.9 mg/L | Standard Deviation 0.87 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | -0.6 mg/L | Standard Deviation 0.71 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | -0.7 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | -1.1 mg/L | Standard Deviation 1.06 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | 0.6 mg/L | Standard Deviation 0.5 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | -1.5 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | -2.3 mg/L | — |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | -0.2 mg/L | Standard Deviation 0.42 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | 0.5 mg/L | Standard Deviation 0.41 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | -5.1 mg/L | Standard Deviation 8.52 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | -4.1 mg/L | Standard Deviation 7.12 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | -5.9 mg/L | Standard Deviation 6.58 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | -3.2 mg/L | Standard Deviation 9.54 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | -1.8 mg/L | Standard Deviation 7.26 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | -3.7 mg/L | Standard Deviation 7.8 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | -4.2 mg/L | Standard Deviation 11.29 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | -6.8 mg/L | Standard Deviation 8.82 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | -4.8 mg/L | Standard Deviation 6.69 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | -5.8 mg/L | Standard Deviation 7.73 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | -4.1 mg/L | Standard Deviation 7.77 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | -5.8 mg/L | Standard Deviation 7.66 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | -6.1 mg/L | Standard Deviation 6.32 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | -5.8 mg/L | Standard Deviation 7.55 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -9.5 mg/L | Standard Deviation 12.15 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 20 | -4.4 mg/L | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 52 | -4.6 mg/L | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 28 | 3.8 mg/L | Standard Deviation 9.55 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 28 | -5.3 mg/L | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 20 | -1.5 mg/L | Standard Deviation 2.39 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 52 | 2.5 mg/L | Standard Deviation 9.89 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 44 | 8.6 mg/L | Standard Deviation 8.55 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 44 | -3.9 mg/L | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 44 | 5.5 mg/L | Standard Deviation 9.39 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Non-responders, Week 36 | 8.3 mg/L | Standard Deviation 12.71 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 28 | 6.8 mg/L | Standard Deviation 9.1 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 20 | -0.5 mg/L | Standard Deviation 1.68 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 52 | 4.9 mg/L | Standard Deviation 10.6 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical responders, Week 36 | -4.9 mg/L | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in Hs-CRP Over Time During Extension Phase | Clinical non-responders, Week 36 | 12.7 mg/L | Standard Deviation 11.2 |
Comparison: Non-responders, Week 44p-value: 0.47495% CI: [-10.28, 21.95]ANCOVA
Comparison: Non-responders, Week 52p-value: 0.72795% CI: [-17.03, 24.3]ANCOVA
Comparison: Responders, Week 20p-value: 0.82295% CI: [-19.83, 15.83]ANCOVA
Comparison: Responders, Week 20p-value: 0.38695% CI: [-20.97, 8.25]ANCOVA
Comparison: Responders, Week 20p-value: 0.13695% CI: [-4.22, 29.95]ANCOVA
Comparison: Responders, Week 28p-value: 0.91295% CI: [-17.87, 19.97]ANCOVA
Comparison: Responders, Week 28p-value: 0.11895% CI: [-27.77, 3.25]ANCOVA
Comparison: Responders, Week 28p-value: 0.17195% CI: [-5.61, 30.65]ANCOVA
Comparison: Responders, Week 36p-value: 0.47995% CI: [-26.5, 12.63]ANCOVA
Comparison: Responders, Week 36p-value: 0.03795% CI: [-33.12, -1.04]ANCOVA
Comparison: Responders, Week 36p-value: 0.46395% CI: [-11.86, 25.65]ANCOVA
Comparison: Responders, Week 44p-value: 0.62795% CI: [-23.59, 14.37]ANCOVA
Comparison: Responders, Week 44p-value: 0.12295% CI: [-27.75, 3.37]ANCOVA
Comparison: Responders, Week 44p-value: 0.24395% CI: [-7.49, 28.89]ANCOVA
Comparison: Responders, Week 52p-value: 0.65895% CI: [-22.95, 14.63]ANCOVA
Comparison: Responders, Week 52p-value: 0.11595% CI: [-27.69, 3.12]ANCOVA
Comparison: Responders, Week 52p-value: 0.26795% CI: [-7.96, 28.06]ANCOVA
Comparison: Non-responders, Week 20p-value: 0.97495% CI: [-9.74, 10.06]ANCOVA
Comparison: Non-responders, Week 20p-value: 0.88295% CI: [-7.61, 6.55]ANCOVA
Comparison: Non-responders, Week 20p-value: 0.98295% CI: [-7.92, 7.75]ANCOVA
Comparison: Non-responders, Week 28p-value: 0.67395% CI: [-8.11, 12.51]ANCOVA
Comparison: Non-responders, Week 28p-value: 0.46795% CI: [-4.64, 10.04]ANCOVA
Comparison: Non-responders, Week 28p-value: 0.58395% CI: [-5.79, 10.23]ANCOVA
Comparison: Non-responders, Week 36p-value: 0.56495% CI: [-13.33, 24.31]ANCOVA
Comparison: Non-responders, Week 36p-value: 0.72895% CI: [-15.74, 11.04]ANCOVA
Comparison: Non-responders, Week 36p-value: 0.4695% CI: [-9.16, 20.08]ANCOVA
Comparison: Non-responders, Week 44p-value: 0.25395% CI: [-8.72, 32.75]ANCOVA
Comparison: Non-responders, Week 44p-value: 0.88495% CI: [-13.67, 15.84]ANCOVA
Comparison: Non-responders, Week 52p-value: 0.7895% CI: [-12.63, 16.78]ANCOVA
Comparison: Non-responders, Week 52p-value: 0.42495% CI: [-9.57, 22.54]ANCOVA
Comparison: Clinical responders, Week 20p-value: 0.84195% CI: [-14.23, 11.62]ANCOVA
Comparison: Clinical responders, Week 20p-value: 0.70295% CI: [-12.94, 8.75]ANCOVA
Comparison: Clinical responders, Week 20p-value: 0.35395% CI: [-6.43, 17.83]ANCOVA
Comparison: Clinical responders, Week 28p-value: 0.7795% CI: [-11.89, 16]ANCOVA
Comparison: Clinical responders, Week 28p-value: 0.36795% CI: [-17.04, 6.37]ANCOVA
Comparison: Clinical responders, Week 28p-value: 0.29195% CI: [-6.09, 20.07]ANCOVA
Comparison: Clinical responders, Week 36p-value: 0.94295% CI: [-20.87, 19.4]ANCOVA
Comparison: Clinical responders, Week 36p-value: 0.16295% CI: [-28.89, 4.91]ANCOVA
Comparison: Clinical responders, Week 36p-value: 0.25395% CI: [-7.96, 29.82]ANCOVA
Comparison: Clinical responders, Week 44p-value: 0.61795% CI: [-16.25, 27.21]ANCOVA
Comparison: Clinical responders, Week 44p-value: 0.51595% CI: [-24.22, 12.24]ANCOVA
Comparison: Clinical responders, Week 44p-value: 0.1895% CI: [-6.53, 34.23]ANCOVA
Comparison: Clinical responders, Week 52p-value: 0.97295% CI: [-21.86, 21.09]ANCOVA
Comparison: Clinical responders, Week 52p-value: 0.58995% CI: [-22.94, 13.1]ANCOVA
Comparison: Clinical responders, Week 52p-value: 0.16895% CI: [-6.07, 34.22]ANCOVA
Comparison: Clinical non-responders, Week 20p-value: 0.71295% CI: [-8.5, 12.36]ANCOVA
Comparison: Clinical non-responders, Week 20p-value: 0.46595% CI: [-8.41, 3.9]ANCOVA
Comparison: Clinical non-responders, Week 20p-value: 0.92495% CI: [-6.83, 7.52]ANCOVA
Comparison: Clinical non-responders, Week 28p-value: 0.93895% CI: [-8.88, 9.6]ANCOVA
Comparison: Clinical non-responders, Week 28p-value: 0.4195% CI: [-3.17, 7.64]ANCOVA
Comparison: Clinical non-responders, Week 28p-value: 0.94195% CI: [-5.89, 6.35]ANCOVA
Comparison: Clinical non-responders, Week 36p-value: 0.87295% CI: [-8.23, 9.67]ANCOVA
Comparison: Clinical non-responders, Week 36p-value: 0.69295% CI: [-6.27, 4.2]ANCOVA
Comparison: Clinical non-responders, Week 36p-value: 0.89695% CI: [-6.32, 5.54]ANCOVA
Comparison: Clinical non-responders, Week 44p-value: 0.82695% CI: [-7.92, 9.87]ANCOVA
Comparison: Clinical non-responders, Week 44p-value: 0.88595% CI: [-4.82, 5.58]ANCOVA
Comparison: Clinical non-responders, Week 44p-value: 0.96495% CI: [-6.03, 5.76]ANCOVA
Comparison: Clinical non-responders, Week 52p-value: 0.80695% CI: [-7.59, 9.72]ANCOVA
Comparison: Clinical non-responders, Week 52p-value: 0.87195% CI: [-4.65, 5.47]ANCOVA
Comparison: Clinical non-responders, Week 52p-value: 0.8595% CI: [-6.28, 5.19]ANCOVA
Secondary
Change From Induction Baseline in IBDQ at Week 52
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function, and social function. Each subscale can be computed with total scores ranging from 10 to 70, 5 to 35, 12 to 84, and 5 to 35, respectively.
Time frame: Baseline, Week 52
Population: Participants from ITT population with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in IBDQ at Week 52 | Responders | 43.9 units on a scale | Standard Deviation 38.06 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 42.8 units on a scale | Standard Deviation 44.13 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 20.8 units on a scale | Standard Deviation 43.58 |
| Double-Blind Induction Phase: Placebo BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | 9.4 units on a scale | Standard Deviation 31.46 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 26.0 units on a scale | Standard Deviation 33.14 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 46.6 units on a scale | Standard Deviation 27.76 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Responders | 56.4 units on a scale | Standard Deviation 14.52 |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | 13.5 units on a scale | Standard Deviation 19.09 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Responders | 82.3 units on a scale | Standard Deviation 35.59 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 25.9 units on a scale | Standard Deviation 47.05 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 70.7 units on a scale | Standard Deviation 46.99 |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | 9.8 units on a scale | Standard Deviation 30.81 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Responders | 45.3 units on a scale | Standard Deviation 49.89 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 2.9 units on a scale | Standard Deviation 35.25 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 26.6 units on a scale | Standard Deviation 53.11 |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | -1.5 units on a scale | Standard Deviation 5.81 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | 0.0 units on a scale | Standard Deviation 0 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Responders | -5.0 units on a scale | — |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 4.8 units on a scale | Standard Deviation 16.42 |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 4.8 units on a scale | Standard Deviation 18.7 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 35.5 units on a scale | Standard Deviation 28.78 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | 24.6 units on a scale | Standard Deviation 23.17 |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 68.0 units on a scale | — |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 45.4 units on a scale | Standard Deviation 36.16 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 34.5 units on a scale | Standard Deviation 4.95 |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | 52.7 units on a scale | Standard Deviation 49.03 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in IBDQ at Week 52 | Clinical non-responders | 59.0 units on a scale | — |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in IBDQ at Week 52 | Non-responders | 41.5 units on a scale | Standard Deviation 24.75 |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Change From Induction Baseline in IBDQ at Week 52 | Clinical responders | 24.0 units on a scale | — |
Comparison: Respondersp-value: 0.79295% CI: [-33.73, 25.9]ANCOVA
Comparison: Respondersp-value: 0.17995% CI: [-8.62, 44.75]ANCOVA
Comparison: Respondersp-value: 0.2395% CI: [-50.87, 12.63]ANCOVA
Comparison: Non-respondersp-value: 0.33795% CI: [-17.54, 50.4]ANCOVA
Comparison: Non-respondersp-value: 0.92495% CI: [-21.75, 23.93]ANCOVA
Comparison: Non-respondersp-value: 0.37395% CI: [-37.69, 14.35]ANCOVA
Comparison: Clinical respondersp-value: 0.81395% CI: [-28.94, 22.79]ANCOVA
Comparison: Clinical respondersp-value: 0.65195% CI: [-18.02, 28.65]ANCOVA
Comparison: Clinical respondersp-value: 0.06595% CI: [-49.12, 1.49]ANCOVA
Comparison: Clinical non-respondersp-value: 0.80295% CI: [-37.61, 48.28]ANCOVA
Comparison: Clinical non-respondersp-value: 0.95595% CI: [-20.46, 21.63]ANCOVA
Comparison: Clinical non-respondersp-value: 0.39595% CI: [-35.73, 14.47]ANCOVA
Secondary
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
Presented as percentage of participants with given number of EIMs at Baseline (BL) and Week (Wk) 52. EIMs of Crohn's disease included anemia, autoimmune hepatitis, axial arthropathy, bronchiectasis, chronic obstructive pulmonary disease, episcleritis, erythema nodosum, iritis, nephrolithiasis, oral aphthous ulcers, peripheral arthropathy, primary sclerosing cholangitis, pyoderma gangrenosum, Sweet's syndrome, uveitis, and venous thromboembolism.
Time frame: Baseline, Week 52
Population: Participants from modified ITT population (all randomized participants who took at least 1 dose of study drug in the Induction Period).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/2 at Wk 52 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/2 at Wk 52 | 7.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/1 at Wk 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 5 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 5 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/1 at Wk 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/0 at Wk 52 | 85.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/0 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 5 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/1 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/missing at Wk 52 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/4 at Wk 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/missing at Wk 52 | 7.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/0 at Wk 52 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/0 at Wk 52 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 5 at BL/0 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/0 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/1 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/4 at Wk 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 5 at BL/1 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 5 at BL/5 at Wk 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/1 at Wk 52 | 7.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 5 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/1 at Wk 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/0 at Wk 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/1 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/0 at Wk 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/0 at Wk 52 | 31.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/1 at Wk 52 | 57.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/1 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/missing at Wk 52 | 5.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/0 at Wk 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/0 at Wk 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/1 at Wk 52 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/2 at Wk 52 | 5.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/2 at Wk 52 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/1 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/0 at Wk 52 | 86.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/2 at Wk 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/0 at Wk 52 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/2 at Wk 52 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/0 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/0 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/1 at Wk 52 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/0 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/1 at Wk 52 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/missing at Wk 52 | 4.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/1 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/5 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/2 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/3 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 4 at BL/missing at Wk 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/missing at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/4 at Wk 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/1 at Wk 52 | 9.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/0 at Wk 52 | 62.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/1 at Wk 52 | 16.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/2 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/missing at Wk 52 | 8.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/missing at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/1 at Wk 52 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/0 at Wk 52 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/1 at Wk 52 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/2 at Wk 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/0 at Wk 52 | 76.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/2 at Wk 52 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/missing at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/0 at Wk 52 | 73.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/2 at Wk 52 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/1 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/1 at Wk 52 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/missing at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/missing at Wk 52 | 5.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/0 at Wk 52 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/2 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/2 at Wk 52 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/missing at Wk 52 | 13.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/1 at Wk 52 | 13.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 3 at BL/0 at Wk 52 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/0 at Wk 52 | 54.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/missing at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/0 at Wk 52 | 85.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/2 at Wk 52 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/2 at Wk 52 | 9.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/1 at Wk 52 | 36.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/1 at Wk 52 | 10.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/1 at Wk 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/0 at Wk 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/missing at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/missing at Wk 52 | 5.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/5 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 2 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/4 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 1 at BL/3 at Wk 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease | 0 at BL/2 at Wk 52 | 0 percentage of participants |
Secondary
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 | 19.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 | 41.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16 | 10.0 percentage of participants |
p-value: 0.09395% CI: [-3.1, 40.5]Cochran-Mantel-Haenszel
p-value: 0.17695% CI: [-6.1, 33.1]Cochran-Mantel-Haenszel
p-value: 0.01795% CI: [6.3, 65.5]Cochran-Mantel-Haenszel
p-value: 0.04495% CI: [0.7, 51.5]Cochran-Mantel-Haenszel
p-value: 0.12195% CI: [-3.5, 29.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 | 11.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16 | 10.0 percentage of participants |
p-value: 0.12195% CI: [-3.5, 29.6]Cochran-Mantel-Haenszel
p-value: 0.19595% CI: [-6.2, 30.7]Cochran-Mantel-Haenszel
p-value: 0.11695% CI: [-4.4, 40.1]Cochran-Mantel-Haenszel
p-value: 0.17895% CI: [-5.8, 31.5]Cochran-Mantel-Haenszel
p-value: 0.03195% CI: [2.8, 58]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16
Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 | 5.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16 | 10.0 percentage of participants |
p-value: 0.39295% CI: [-8.7, 22.2]Cochran-Mantel-Haenszel
p-value: 0.58495% CI: [-8.8, 15.7]Cochran-Mantel-Haenszel
p-value: 0.19995% CI: [-6.8, 32.9]Cochran-Mantel-Haenszel
p-value: 0.43995% CI: [-10.6, 24.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16
Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 | 5.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 | 5.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 | 13.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16 | 0.0 percentage of participants |
p-value: 0.56495% CI: [-8.1, 14.9]Cochran-Mantel-Haenszel
p-value: 0.58495% CI: [-8.8, 15.7]Cochran-Mantel-Haenszel
p-value: 0.32695% CI: [-8.7, 26.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Steroid-free modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Participants from ITT population taking corticosteroids at Induction Baseline and Daily Stool Frequency \>= 4.0 OR Daily Abdominal Pain \>= 2.0 at Induction Baseline. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 28 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 52 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 28 | 41.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 20 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 36 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 36 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 20 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 44 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 20 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 44 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 52 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 44 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 52 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 52 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 28 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 36 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 20 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 36 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 44 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 52 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 20 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 28 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 36 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 52 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 20 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 44 | 35.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 36 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 20 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 28 | 16.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 44 | 28.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 44 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 36 | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 44 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 36 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 28 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 52 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 52 | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 20 | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Responders, Week 20 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 28 | 28.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time | Non-responders, Week 52 | 0 percentage of participants |
Comparison: Responders, Week 20p-value: 195% CI: [-62.2, 95.6]Chi-squared
Comparison: Responders, Week 20p-value: 0.59295% CI: [-21.3, 79.6]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-64.8, 38.2]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-80, 80]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-39.7, 64.7]Chi-squared
Comparison: Responders, Week 28p-value: 0.54595% CI: [-83.2, 23.2]Chi-squared
Comparison: Responders, Week 36p-value: 0.46495% CI: [10, 90]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-39.7, 64.7]Chi-squared
Comparison: Responders, Week 36p-value: 0.18295% CI: [-90, -10]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-62.2, 95.6]Chi-squared
Comparison: Responders, Week 44p-value: 0.59295% CI: [-21.3, 79.6]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-64.8, 38.2]Chi-squared
Comparison: Responders, Week 52p-value: 0.42995% CI: [28.9, 100]Chi-squared
Comparison: Responders, Week 52p-value: 0.59295% CI: [-21.3, 79.6]Chi-squared
Comparison: Responders, Week 52p-value: 0.45595% CI: [-71.1, 4.4]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.19195% CI: [-14, 77.4]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-22.1, 22.1]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-24, 7.3]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.53895% CI: [-24.5, 71.2]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-29.8, 29.8]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-35.3, 27]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.51595% CI: [-26.7, 50.1]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-22.1, 22.1]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-23.6, 31.9]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.53895% CI: [-24.5, 71.2]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.47895% CI: [-37.8, 4.4]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-35.3, 27]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.51595% CI: [-26.7, 50.1]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-17.9, 34.6]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-23.6, 31.9]Chi-squared
Comparison: Clinical Responders, Week 20p-value: 0.34495% CI: [-21.9, 71.9]Chi-squared
Comparison: Clinical Responders, Week 20p-value: 0.42995% CI: [-17.8, 53.5]Chi-squared
Comparison: Clinical Responders, Week 20p-value: 195% CI: [-46.4, 25]Chi-squared
Comparison: Clinical Responders, Week 28p-value: 195% CI: [-40.4, 57.1]Chi-squared
Comparison: Clinical Responders, Week 28p-value: 0.67195% CI: [-29.9, 46.6]Chi-squared
Comparison: Clinical Responders, Week 28p-value: 0.65695% CI: [-56.7, 30.5]Chi-squared
Comparison: Clinical Responders, Week 36p-value: 0.62795% CI: [-31.4, 64.7]Chi-squared
Comparison: Clinical Responders, Week 36p-value: 0.70195% CI: [-27.7, 46.7]Chi-squared
Comparison: Clinical Responders, Week 36p-value: 0.60395% CI: [-56.2, 18.1]Chi-squared
Comparison: Clinical Responders, Week 44p-value: 0.62795% CI: [-31.4, 64.7]Chi-squared
Comparison: Clinical Responders, Week 44p-value: 195% CI: [-34.2, 39]Chi-squared
Comparison: Clinical Responders, Week 44p-value: 195% CI: [-47.6, 38]Chi-squared
Comparison: Clinical Responders, Week 52p-value: 0.34495% CI: [-21.9, 71.9]Chi-squared
Comparison: Clinical Responders, Week 52p-value: 0.24895% CI: [-10.9, 60.9]Chi-squared
Comparison: Clinical Responders, Week 52p-value: 195% CI: [-46.4, 25]Chi-squared
Secondary
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 36 | 13.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 20 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 44 | 26.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 44 | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 52 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 36 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 44 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 52 | 46.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 28 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 20 | 13.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 28 | 6.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 36 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 28 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 52 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 52 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 20 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 52 | 57.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 20 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 52 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 20 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 28 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 36 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 44 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 52 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 28 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 36 | 35.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 36 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 28 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 44 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 52 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 44 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 36 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 52 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 28 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 44 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
Comparison: Responders, Week 20p-value: 195% CI: [-77.5, 77.5]Chi-squared
Comparison: Responders, Week 20p-value: 0.60895% CI: [-20.8, 70.8]Chi-squared
Comparison: Responders, Week 20p-value: 0.10595% CI: [-84.6, -15.4]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-77.5, 77.5]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-49, 49]Chi-squared
Comparison: Responders, Week 28p-value: 0.56595% CI: [-79.3, 19.3]ANOVA
Comparison: Responders, Week 36p-value: 0.46795% CI: [15.4, 84.6]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-49, 49]Chi-squared
Comparison: Responders, Week 36p-value: 0.10595% CI: [-84.6, -15.4]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-64.5, 89.5]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-35.7, 60.7]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-66, 31]Chi-squared
Comparison: Responders, Week 52p-value: 0.46795% CI: [15.4, 84.6]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-35.7, 60.7]Chi-squared
Comparison: Responders, Week 52p-value: 0.10595% CI: [-84.6, -15.4]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.24995% CI: [-19.6, 72.9]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-28.2, 18.2]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.51195% CI: [-30.5, 3.9]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.1495% CI: [-11.4, 78.1]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.56995% CI: [-14.6, 34.6]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-19.7, 28.5]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.24995% CI: [-19.6, 72.9]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-28.2, 18.2]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-29, 24.6]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.61395% CI: [-35.1, 61.8]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-34.8, 31.5]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.61595% CI: [-45.9, 14.8]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.5695% CI: [-27.5, 67.5]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-26.8, 36.8]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-37.7, 19.9]Chi-squared
Comparison: Clinical responders, Week 20p-value: 195% CI: [-37.1, 57.1]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.58895% CI: [-26.1, 46.1]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.05895% CI: [-64.8, -15.2]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.63195% CI: [-29.9, 63.2]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.59795% CI: [-25.7, 44.8]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-46.7, 30]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.36195% CI: [-18.5, 71.8]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.81295% CI: [-39.6, 31]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.34595% CI: [-61.3, 6.3]Chi-squared
Comparison: Clinical responders, Week 44p-value: 195% CI: [-37.1, 57.1]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.58895% CI: [-26.1, 46.1]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.65795% CI: [-53.9, 23.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.63595% CI: [-25.4, 65.4]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.57395% CI: [-25.7, 46.7]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.17695% CI: [-68.3, -0.1]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-35.4, 10.4]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-35.4, 10.4]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-35.4, 10.4]Chi-squared
Secondary
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Steroid-free clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 28 | 6.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 28 | 26.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 20 | 13.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 44 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 52 | 13.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 36 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 36 | 6.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 20 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 28 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 52 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 44 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 52 | 26.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 36 | 26.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 44 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 52 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 52 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 20 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 28 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 36 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 44 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 52 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 28 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 52 | 8.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 28 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 20 | 28.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 44 | 35.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 36 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 52 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 36 | 35.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 44 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 36 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 28 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 52 | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 36 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 44 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 52 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 28 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 44 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical responders, Week 28 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 52 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Clinical non-responders, Week 28 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time | Non-responders, Week 36 | 0 percentage of participants |
Comparison: Non-responders, Week 20p-value: 0.24995% CI: [-19.6, 72.9]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.81295% CI: [-39.6, 31]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-77.5, 77.5]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-49, 49]Chi-squared
Comparison: Responders, Week 20p-value: 0.10595% CI: [-84.6, -15.4]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-64.5, 89.5]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-35.7, 60.7]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-66, 31]Chi-squared
Comparison: Responders, Week 36p-value: 0.44495% CI: [29, 96]Chi-squared
Comparison: Responders, Week 36p-value: 0.61995% CI: [-22.4, 72.4]Chi-squared
Comparison: Responders, Week 36p-value: 0.23195% CI: [-71, -4]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-71, -4]Chi-squared
Comparison: Responders, Week 44p-value: 0.61995% CI: [-22.4, 72.4]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-66, 31]Chi-squared
Comparison: Responders, Week 52p-value: 0.13395% CI: [45, 100]Chi-squared
Comparison: Responders, Week 52p-value: 0.31595% CI: [-7.5, 82.5]Chi-squared
Comparison: Responders, Week 52p-value: 0.48795% CI: [-55, 5]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.48795% CI: [-30.5, 3.9]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.51195% CI: [-30.5, 3.9]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.1495% CI: [-11.4, 78.1]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.56995% CI: [-14.6, 34.6]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-19.7, 28.5]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.44795% CI: [-23.9, 50.6]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-19.3, 6]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-19.7, 28.5]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.5695% CI: [-27.5, 67.5]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.23195% CI: [-40.2, 0.2]Chi-squared
Comparison: Clinical responders, Week 44p-value: 195% CI: [-51.8, 38.5]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-37.7, 19.9]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-32.4, 45.7]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-28.2, 18.2]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-29, 24.6]Chi-squared
Comparison: Clinical responders, Week 20p-value: 195% CI: [-37.1, 57.1]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.795% CI: [-45.7, 22.8]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.05895% CI: [-64.8, -15.2]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.35495% CI: [-22.5, 69.2]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.4595% CI: [-18.1, 50.4]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-39.1, 35.8]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.35495% CI: [-22.5, 69.2]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.795% CI: [-24.6, 42.7]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.62195% CI: [-46.2, 17.9]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.65795% CI: [-53.9, 23.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.35495% CI: [-22.5, 69.2]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.4595% CI: [-18.1, 50.4]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.62195% CI: [-46.2, 17.9]Chi-squared
Secondary
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52
Steroid-free endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus Induction Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Baseline, Week 52
Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical responders | 13.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Responders | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Non-responders | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical responders | 16.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Non-responders | 8.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical responders | 35.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Responders | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical responders | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Non-responders | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52 | Non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-55, 5]Chi-squared
Comparison: Respondersp-value: 0.60895% CI: [-20.8, 70.8]Chi-squared
Comparison: Respondersp-value: 0.48795% CI: [-55, 5]Chi-squared
Comparison: Non-respondersp-value: 0.2595% CI: [-15.1, 55.1]Chi-squared
Comparison: Non-respondersp-value: 0.44495% CI: [-7.3, 24]Chi-squared
Comparison: Non-respondersp-value: 0.37595% CI: [-9.4, 31.6]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-31.1, 37.8]Chi-squared
Comparison: Clinical respondersp-value: 0.21595% CI: [-8, 52.8]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-29.5, 27.8]Chi-squared
Secondary
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52
Steroid-free remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2 point reduction versus Induction Baseline and no subscore \> 1 in any individual variable. Clinical remission: Average daily stool frequency ≤ 1.5 and not worse than baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record.
Time frame: Baseline, Week 52
Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Responders | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical Responders | 13.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical Responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical Responders | 21.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Responders | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical Responders | 12.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Non-responders | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical Responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical Responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52 | Clinical non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 0.48795% CI: [-55, 5]Chi-squared
Comparison: Non-respoondersp-value: 0.37595% CI: [-9.4, 31.6]Chi-squared
Comparison: Respondersp-value: 195% CI: [-55, 5]Chi-squared
Comparison: Respondersp-value: 195% CI: [-32.5, 57.5]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-30.5, 3.9]Chi-squared
Comparison: Clinical respondersp-value: 0.65195% CI: [-19.4, 35.6]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-29.5, 27.8]Chi-squared
Secondary
Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16
Endoscopic remission: SES-CD ≤ 4 and at least two point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16 | 2.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16 | 12.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16 | 18.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16 | 36.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16 | 25.7 percentage of participants |
p-value: 0.11995% CI: [-2.5, 22.1]Cochran-Mantel-Haenszel
p-value: 0.03495% CI: [1.1, 29.7]Cochran-Mantel-Haenszel
p-value: 0.00495% CI: [7.3, 39.2]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [14.2, 50.5]Cochran-Mantel-Haenszel
p-value: <0.00695% CI: [6.6, 39.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus induction baseline and no subscore \> 1 in any individual variable. Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than induction baseline AND average daily abdominal pain \<= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Participants with daily stool frequency \>= 4.0 or daily abdominal pain \>= 2.0 at Induction Baseline. Non responder imputation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 17.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders | 29.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders | 12.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 7.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 22.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 6.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 4.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 15.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders | 10.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 100 percentage of participants |
Comparison: Respondersp-value: 0.62495% CI: [-48.4, 14.6]Chi-squared
Comparison: Respondersp-value: 195% CI: [-28.3, 36.1]Chi-squared
Comparison: Respondersp-value: 0.36395% CI: [-48, 9.1]Chi-squared
Comparison: Non-respondersp-value: 0.49595% CI: [-2.1, 14.2]Chi-squared
Comparison: Non-respondersp-value: 0.06695% CI: [-0.6, 30.6]Chi-squared
Comparison: Clinical respondersp-value: 0.64595% CI: [-30.3, 8.9]Chi-squared
Comparison: Clinical respondersp-value: 0.68695% CI: [-16.8, 25.5]Chi-squared
Comparison: Clinical respondersp-value: 0.72195% CI: [-19.5, 28.2]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-4.3, 13.9]Chi-squared
Secondary
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 36 | 70.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 56.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 15.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 59.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 40.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 28.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 52 | 55.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 18.8 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 28 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 15.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 20 | 65.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 59.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 9.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 44 | 45.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 15.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 43.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 64.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 28 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 64.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 44 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 48.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 28 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 17.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 44 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 55.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 52 | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 20 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 36 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 14.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 20.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 55.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 44.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 51.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 17.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 17.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 8.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 8.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 20 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 36.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 28 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 36 | 30.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 47.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 31.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 31.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 36.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 83.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 22.2 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 11.1 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 20.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 44 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 20 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 28 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 36 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 28 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 36 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Clinical non- responders, Week 20 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase | Non-responders, Week 52 | 50.0 percentage of participants |
Comparison: Responders, Week 20p-value: 0.67195% CI: [-55.5, 25.5]Chi-squared
Comparison: Responders, Week 20p-value: 0.71895% CI: [-19.8, 39.8]Chi-squared
Comparison: Responders, Week 20p-value: 0.46195% CI: [-52.4, 22.4]Chi-squared
Comparison: Responders, Week 28p-value: 0.0395% CI: [-85.5, -14.5]Chi-squared
Comparison: Responders, Week 28p-value: 0.48395% CI: [-42.9, 17.9]Chi-squared
Comparison: Responders, Week 28p-value: 0.43195% CI: [-50.8, 20.8]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-31.1, 41.1]Chi-squared
Comparison: Responders, Week 36p-value: 0.63595% CI: [-38.6, 23.6]Chi-squared
Comparison: Responders, Week 36p-value: 0.05695% CI: [-74.8, -5.2]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-47.5, 32.5]Chi-squared
Comparison: Responders, Week 44p-value: 0.29695% CI: [-14.7, 49.7]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-42.4, 32.4]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-45.9, 35.9]Chi-squared
Comparison: Responders, Week 52p-value: 0.495% CI: [-17.7, 45.2]Chi-squared
Comparison: Responders, Week 52p-value: 0.43995% CI: [-52.4, 22.4]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.25995% CI: [-12.8, 56.6]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.3195% CI: [-30.6, 9.7]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.09795% CI: [-38.8, -0.1]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.18195% CI: [-8.5, 57.2]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.82695% CI: [-15.9, 20]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-21.2, 16.1]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.36995% CI: [-16.7, 45.4]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-18.2, 16.4]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-21.2, 16.1]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.6695% CI: [-20.2, 42.7]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.90895% CI: [-19.7, 17.5]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.44695% CI: [-27.8, 7.7]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.13595% CI: [-9.5, 50.8]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.30695% CI: [-5.7, 28.1]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.68695% CI: [-13.4, 20.7]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.75495% CI: [-25.4, 35.2]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.54895% CI: [-32.6, 17.3]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.1295% CI: [-50.1, 5]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.40395% CI: [-44.5, 17.7]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.53395% CI: [-33, 17]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.53995% CI: [-37.2, 19.4]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.75495% CI: [-25.4, 35.2]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.25695% CI: [-39.4, 10.3]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.05595% CI: [-54.7, -0.8]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.88795% CI: [-28.8, 33.2]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.25695% CI: [-10.3, 39.4]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.51895% CI: [-36, 17.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.69595% CI: [-25.1, 37.6]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.37395% CI: [-13.5, 36.4]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.62895% CI: [-34.6, 20.8]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 195% CI: [-30.6, 0.6]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 195% CI: [-22.4, 20.9]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.25195% CI: [-30.6, 0.6]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-18.7, 17.7]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.50195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.48895% CI: [-3, 22.1]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 0.23295% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 0.50195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 0.48895% CI: [-3, 22.1]Chi-squared
Secondary
Percentage of Participants Who Achieve Clinical Remission at Week 12
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 12
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission at Week 12 | 10.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 12 | 10.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 12 | 29.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 12 | 13.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Remission at Week 12 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Remission at Week 12 | 8.6 percentage of participants |
p-value: 0.89695% CI: [-15, 13.1]Cochran-Mantel-Haenszel
p-value: 0.0595% CI: [0, 37.3]Cochran-Mantel-Haenszel
p-value: 0.70295% CI: [-12.4, 18.4]Cochran-Mantel-Haenszel
p-value: 0.11795% CI: [-3.6, 32.2]Cochran-Mantel-Haenszel
p-value: 0.73695% CI: [-16.4, 11.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Participants from ITT population with man average daily stool frequency \>= 2.5 and average daily abdominal pain \>= 2.0 at Induction Baseline. Participants Receiving Upadacitinib in Induction. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 23.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 41.2 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 44.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 21.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 44.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 21.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 41.2 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 55.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 35.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 21.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 44.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 47.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 7.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 16.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 6.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 6.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 6.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 13.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 26.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 26.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 22.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 11.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 44.4 percentage of participants |
Comparison: Responders, Week 20p-value: 0.5895% CI: [-71.9, 16.3]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-53.6, 39.7]Chi-squared
Comparison: Responders, Week 20p-value: 0.5895% CI: [-72.2, 23.3]Chi-squared
Comparison: Responders, Week 28p-value: 0.28795% CI: [-83, 5.2]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-53, 41.9]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-69.4, 38.3]Chi-squared
Comparison: Responders, Week 36p-value: 0.5895% CI: [-71.9, 16.3]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-41.9, 53]Chi-squared
Comparison: Responders, Week 36p-value: 0.5895% CI: [-72.2, 23.3]Chi-squared
Comparison: Responders, Week 44p-value: 0.10395% CI: [-76.9, -12]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-41.9, 53]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-58.3, 49.4]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-48.7, 48.7]Chi-squared
Comparison: Responders, Week 52p-value: 0.63795% CI: [-29.7, 63]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-60, 33.3]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.5795% CI: [-29.4, 66.6]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.3395% CI: [-39.7, 10.2]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-40, 19.4]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.5795% CI: [-29.4, 66.6]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.3395% CI: [-39.7, 10.2]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-33.8, 35.4]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-42.6, 39.7]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.195% CI: [-42.9, 0.1]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-33.8, 35.4]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-33.8, 45.3]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.59895% CI: [-29.9, 14.6]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-30.7, 24.3]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.46895% CI: [-24.7, 50.4]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-15.7, 28.1]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.53895% CI: [-15.2, 45.4]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.69295% CI: [-48, 25.6]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.38895% CI: [-46.9, 17.9]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.41895% CI: [-54.8, 16.9]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.44895% CI: [-54.1, 20]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.4395% CI: [-47.4, 19.9]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-42.8, 37.6]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.40695% CI: [-55.3, 12.9]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.38895% CI: [-46.9, 17.9]Chi-squared
Comparison: Clinical responders, Week 36p-value: 195% CI: [-46.5, 30.8]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.20495% CI: [-54.7, 4.1]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.90795% CI: [-34.9, 31]Chi-squared
Comparison: Clinical responders, Week 44p-value: 195% CI: [-40.2, 36.3]Chi-squared
Comparison: Clinical responders, Week 52p-value: 195% CI: [-28.4, 41.3]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.4595% CI: [-15.5, 48.4]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.66195% CI: [-27, 46.6]Chi-squared
Secondary
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non responder imputation. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 52 | 5.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 40.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 28 | 5.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 9.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 45.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 34.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 34.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 45.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 9.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 44 | 5.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 12.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 28.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 21.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 28.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 56.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 8.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 8.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 37.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 41.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 37.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 44.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 41.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 8.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 2.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 5.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 52 | 4.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 31.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 31.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 31.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 31.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 8.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 8.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 30.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 30.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction | Clinical non-responders, Week 44 | 0 percentage of participants |
Comparison: Clinical responders, Week 36p-value: 0.77395% CI: [-20.6, 27.7]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-47.5, 32.5]Chi-squared
Comparison: Responders, Week 20p-value: 0.76595% CI: [-27.8, 37.8]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-42.4, 32.4]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-47.5, 32.5]Chi-squared
Comparison: Responders, Week 28p-value: 0.50295% CI: [-21.4, 43.9]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-32.9, 42.9]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-42.3, 37.3]Chi-squared
Comparison: Responders, Week 36p-value: 0.1895% CI: [-9.5, 54.5]Chi-squared
Comparison: Responders, Week 36p-value: 0.70295% CI: [-45.6, 25.6]Chi-squared
Comparison: Responders, Week 44p-value: 0.21495% CI: [-58.9, 3.9]Chi-squared
Comparison: Responders, Week 44p-value: 0.08695% CI: [-2.5, 60]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-37.2, 37.2]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-31.6, 46.6]Chi-squared
Comparison: Responders, Week 52p-value: 0.05195% CI: [1.4, 63.6]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-34.8, 34.8]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.07595% CI: [-5, 60]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.70595% CI: [-18.6, 11.2]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-20, 12.4]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.07595% CI: [-5, 60]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.70595% CI: [-18.6, 11.2]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-17.4, 18.5]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-20.5, 21.8]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.34895% CI: [-18, 5.2]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.68695% CI: [-13.4, 20.7]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.61695% CI: [-19.8, 34.8]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.4295% CI: [-20.5, 7.3]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-20, 12.4]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-20.5, 21.8]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-14.4, 13.3]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.68695% CI: [-13.4, 20.7]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.55595% CI: [-21.9, 40.6]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.8395% CI: [-27.2, 21.8]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.51895% CI: [-36, 17.9]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.42895% CI: [-18.6, 43.6]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.75795% CI: [-20.7, 28.4]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.74595% CI: [-23.2, 32.4]Chi-squared
Comparison: Clinical responders, Week 36p-value: 195% CI: [-34.6, 23]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.83895% CI: [-29.4, 23.8]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.49795% CI: [-40, 14.1]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.40495% CI: [-14, 34.9]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.83895% CI: [-29.4, 23.8]Chi-squared
Comparison: Clinical responders, Week 52p-value: 195% CI: [-24.4, 31.6]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.17495% CI: [-7, 39.8]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.61195% CI: [-19.1, 32.3]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.48895% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 0.48895% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-13.4, 13]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-14.6, 4.6]Chi-squared
Secondary
Percentage of Participants Who Achieve Clinical Response at Week 16
Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response at Week 16 | 32.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response at Week 16 | 43.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response at Week 16 | 56.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response at Week 16 | 47.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response at Week 16 | 61.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response at Week 16 | 48.6 percentage of participants |
p-value: 0.35395% CI: [-11.7, 32.7]Cochran-Mantel-Haenszel
p-value: 0.0595% CI: [0, 45.5]Cochran-Mantel-Haenszel
p-value: 0.26895% CI: [-9.6, 34.6]Cochran-Mantel-Haenszel
p-value: 0.01895% CI: [4.8, 51.2]Cochran-Mantel-Haenszel
p-value: 0.20495% CI: [-8.1, 37.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Clinical response was defined as average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 28 | 85.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 78.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 52 | 55.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 21.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 28.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 20 | 85.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 40.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 78.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 65.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 43.8 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 15.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 28 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 78.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 44 | 87.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 52 | 87.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 78.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 26.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 93.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 44 | 81.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 65.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 72.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 26.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 52 | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 26.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 4.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 28 | 81.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 69.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 29.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 62.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 41.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 36 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 21.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 52 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 57.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 20 | 80.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 28 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 36 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 39.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 26.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 78.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 47.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 7.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 7.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 83.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 22.2 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 20 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 28 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase | Non-clinical responders, Week 44 | 33.3 percentage of participants |
Comparison: Responders, Week 20p-value: 0.53695% CI: [-0.6, 30.6]Chi-squared
Comparison: Responders, Week 20p-value: 0.23895% CI: [-0.6, 30.6]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-34.3, 24.3]Chi-squared
Comparison: Responders, Week 28p-value: 0.60695% CI: [-43.8, 23.8]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-28.5, 21]Chi-squared
Comparison: Responders, Week 28p-value: 0.18195% CI: [-59.2, 9.2]Chi-squared
Comparison: Responders, Week 36p-value: 0.28195% CI: [6, 44]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-28.5, 28.5]Chi-squared
Comparison: Responders, Week 36p-value: 0.23195% CI: [-61.3, 11.3]Chi-squared
Comparison: Responders, Week 44p-value: 0.09995% CI: [5.8, 69.2]Chi-squared
Comparison: Responders, Week 44p-value: 0.05295% CI: [2.2, 60.3]Chi-squared
Comparison: Responders, Week 44p-value: 0.70995% CI: [-47.4, 27.4]Chi-squared
Comparison: Responders, Week 52p-value: 0.19495% CI: [0.9, 64.1]Chi-squared
Comparison: Responders, Week 52p-value: 0.495% CI: [-17.7, 45.2]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-42.9, 32.9]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.47795% CI: [-18.6, 51.1]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.83395% CI: [-26.4, 21.3]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.73295% CI: [-30.9, 21.7]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.46895% CI: [-15.4, 54.2]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.33995% CI: [-34.1, 11.7]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.26395% CI: [-39.3, 10.2]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.69795% CI: [-22.3, 46]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.8895% CI: [-23.2, 19.9]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.35595% CI: [-32.7, 11.2]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-27.1, 37.1]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.89195% CI: [-19.6, 22.6]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.77995% CI: [-25.8, 19.3]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.67895% CI: [-23.7, 39.9]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.66395% CI: [-16, 25.2]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.49495% CI: [-28.7, 11]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.08395% CI: [7.6, 36.2]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.15195% CI: [-2.1, 32]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.99395% CI: [-24, 23.8]Chi-squared
Comparison: Clinical responders, Week 20p-value: 195% CI: [-22.4, 24.1]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-25.4, 26.3]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.41795% CI: [-31.3, 12.9]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.12595% CI: [-46.7, 6.2]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.49795% CI: [-14.1, 40]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.295% CI: [-46.1, 9.6]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.17795% CI: [-7.9, 50.8]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.07495% CI: [-1.4, 46.2]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.58595% CI: [-36.1, 20.3]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.17795% CI: [-7.9, 50.8]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.34395% CI: [-12.7, 36.8]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.58595% CI: [-36.1, 20.3]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.53995% CI: [-50.1, -9.9]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.27795% CI: [-40.8, 9.3]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.42295% CI: [-42.9, 11.5]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-46.5, 46.5]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.45495% CI: [-34.9, 13.5]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.36495% CI: [-41.1, 5.4]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.54495% CI: [-35.2, 55.2]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.66395% CI: [-25.5, 14.6]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.25195% CI: [-30.6, 0.6]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 0.60695% CI: [-21.2, 10.8]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-21.7, 16]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-18.7, 17.7]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 0.50195% CI: [-23.1, 3.1]Chi-squared
Secondary
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 | 16.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 | 20.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 | 29.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 | 38.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 | 30.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16 | 20.0 percentage of participants |
p-value: 0.56495% CI: [-12.5, 22.9]Cochran-Mantel-Haenszel
p-value: 0.22195% CI: [-7.2, 31.2]Cochran-Mantel-Haenszel
p-value: 0.03695% CI: [1.4, 43]Cochran-Mantel-Haenszel
p-value: 0.17995% CI: [-6.2, 33.1]Cochran-Mantel-Haenszel
p-value: 0.67795% CI: [-14.3, 22]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Endoscopic healing was defined as SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore \>= 1 at Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 9.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 9.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Responders | 15.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 15.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 21.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Responders | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 8.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 31.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Responders | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 9.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 8.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 10.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Healing at Week 52 | Clinical responders | 0 percentage of participants |
Comparison: Respondersp-value: 0.60695% CI: [-23.8, 43.8]Chi-squared
Comparison: Respondersp-value: 0.03495% CI: [5.9, 64.1]Chi-squared
Comparison: Respondersp-value: 0.53295% CI: [-30.6, 0.6]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-20.5, 21.8]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-14.4, 13.3]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-16, 14.6]Chi-squared
Comparison: Clinical respondersp-value: 0.3595% CI: [-11.7, 35.8]Chi-squared
Comparison: Clinical respondersp-value: 0.03495% CI: [2, 41.3]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-15.9, 18.3]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-30.6, 0.6]Chi-squared
Comparison: Clinical non-respondersp-value: 0.66395% CI: [-25.5, 14.6]Chi-squared
Comparison: Clinical non-respondersp-value: 0.25195% CI: [-30.6, 0.6]Chi-squared
Secondary
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Endoscopic Improvement: SES-CD reduction from Induction Baseline \> 50% or endoscopic remission. Endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus Induction Baseline and no subscore \> 1 in any individual variable. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 15.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Responders | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 34.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Responders | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 35.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Responders | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 11.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 44.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 9.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Responders | 30.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 36.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Responders | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 16.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 11.1 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical responders | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Non-responders | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Improvement at Week 52 | Clinical non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-41, 41]Chi-squared
Comparison: Respondersp-value: 0.25795% CI: [-12.8, 50.3]Chi-squared
Comparison: Respondersp-value: 0.4495% CI: [-55.9, 15.9]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-24.3, 19.3]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-16.5, 15]Chi-squared
Comparison: Non-respondersp-value: 0.4495% CI: [-55.9, 15.9]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-28.7, 31.4]Chi-squared
Comparison: Clinical respondersp-value: 0.40495% CI: [-14, 34.9]Chi-squared
Comparison: Clinical respondersp-value: 0.85995% CI: [-24.8, 29.7]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-30.6, 0.6]Chi-squared
Comparison: Clinical non-respondersp-value: 0.66395% CI: [-25.5, 14.6]Chi-squared
Comparison: Clinical non-respondersp-value: 0.25195% CI: [-30.6, 0.6]Chi-squared
Secondary
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Responders | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 3.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 5.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 15.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Responders | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 21.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 24.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 8.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Responders | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 26.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Responders | 10.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Responders | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Non-Responders | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Remission at Week 52 | Clinical Non-Responders | 0 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-35.5, 35.5]Chi-squared
Comparison: Respondersp-value: 0.48395% CI: [-17.9, 42.9]Chi-squared
Comparison: Respondersp-value: 0.63395% CI: [-41.6, 11.6]Chi-squared
Comparison: Non-respondersp-value: 0.42495% CI: [-12.7, 26.4]Chi-squared
Comparison: Non-respondersp-value: 0.61495% CI: [-5.6, 17]Chi-squared
Comparison: Non-respondersp-value: 0.14995% CI: [-2.4, 30.9]Chi-squared
Comparison: Clinical respondersp-value: 0.68495% CI: [-19.1, 30.7]Chi-squared
Comparison: Clinical respondersp-value: 0.40495% CI: [-11.5, 28.5]Chi-squared
Comparison: Clinical respondersp-value: 0.4795% CI: [-12.8, 34.1]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-11.3, 20.3]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-14.6, 4.6]Chi-squared
Secondary
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Endoscopic response was defined as SES-CD at least 25% reduction from Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 40.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Responders | 60.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 20.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 15.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 57.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Responders | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 20.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 55.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Responders | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Responders | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 16.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Responders | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 22.2 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 40.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical responders | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Non-responders | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 0.66995% CI: [-21.9, 51.9]Chi-squared
Comparison: Respondersp-value: 0.34395% CI: [-15.2, 45.2]Chi-squared
Comparison: Respondersp-value: 0.44295% CI: [-57.2, 17.2]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-23.4, 32.2]Chi-squared
Comparison: Non-respondersp-value: 0.60195% CI: [-13.6, 23.5]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-18.2, 21.7]Chi-squared
Comparison: Clinical respondersp-value: 0.30195% CI: [-14.5, 47.5]Chi-squared
Comparison: Clinical respondersp-value: 0.25695% CI: [-10.3, 39.4]Chi-squared
Comparison: Clinical respondersp-value: 0.91795% CI: [-26.5, 29.5]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-37.5, -2.5]Chi-squared
Comparison: Clinical non-respondersp-value: 0.69795% CI: [-28.8, 17.3]Chi-squared
Comparison: Clinical non-respondersp-value: 0.12695% CI: [-37.5, -2.5]Chi-squared
Secondary
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 21.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 71.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 46.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 20 | 70.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 34.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 21.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 28.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 28 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 5.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 65.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 15.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 78.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 20 | 87.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 52 | 87.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 44 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 28 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 57.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 78.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 85.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 69.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 93.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 65.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 26.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 23.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 44 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 26.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 62.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 29.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 38.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 52 | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 65.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 4.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 28 | 81.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 57.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 7.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 7.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 20 | 70.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 28 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 36 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 52 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 26.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 21.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 21.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 63.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 70.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 83.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 83.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 22.2 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 40.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 28 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 52 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 20 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 44 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 44 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Non-responders, Week 28 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase | Clinical non-responders, Week 20 | 0 percentage of participants |
Comparison: Responders, Week 20p-value: 0.63395% CI: [-13, 48]Chi-squared
Comparison: Responders, Week 20p-value: 0.002495% CI: [9.9, 50.1]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-34.8, 34.8]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-39.8, 29.8]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-24.7, 27.2]Chi-squared
Comparison: Responders, Week 28p-value: 0.38495% CI: [-55.1, 15.1]Chi-squared
Comparison: Responders, Week 36p-value: 0.28195% CI: [6, 44]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-28.5, 28.5]Chi-squared
Comparison: Responders, Week 36p-value: 0.10895% CI: [-70.8, 0.8]Chi-squared
Comparison: Responders, Week 44p-value: 0.68695% CI: [-27.6, 52.6]Chi-squared
Comparison: Responders, Week 44p-value: 0.12695% CI: [-5.5, 55.5]Chi-squared
Comparison: Responders, Week 44p-value: 0.70995% CI: [-47.4, 27.4]Chi-squared
Comparison: Responders, Week 52p-value: 0.09995% CI: [5.8, 69.2]Chi-squared
Comparison: Responders, Week 52p-value: 0.25795% CI: [-12.8, 50.3]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-38, 38]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.46595% CI: [-19.5, 50.7]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.74595% CI: [-19.3, 27]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.51295% CI: [-32.6, 16.1]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.28195% CI: [-12.2, 57.2]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.48695% CI: [-30.8, 14.6]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.21295% CI: [-39.5, 8]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.69795% CI: [-22.3, 46]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.8895% CI: [-23.2, 19.9]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.35595% CI: [-32.7, 11.2]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.67895% CI: [-23.7, 39.9]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.87395% CI: [-18.6, 21.9]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.9995% CI: [-22.3, 22]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.67895% CI: [-23.7, 39.9]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.66395% CI: [-16, 25.2]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.49495% CI: [-28.7, 11]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.16995% CI: [-1.6, 48.1]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.00595% CI: [11.5, 49.7]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.96395% CI: [-26.8, 28.1]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.72995% CI: [-19.8, 33.2]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.80495% CI: [-25.8, 20]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.30695% CI: [-41.1, 13.1]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.49795% CI: [-14.1, 40]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.99395% CI: [-24, 23.8]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.10195% CI: [-51.2, 4.1]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.65595% CI: [-24, 38.3]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.22195% CI: [-9, 40]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.58595% CI: [-36.1, 20.3]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.12495% CI: [-4.8, 53.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.23495% CI: [-9.5, 39.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.74195% CI: [-32.9, 23.4]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.54495% CI: [-44, -6]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.23895% CI: [-38.2, 7.3]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.36495% CI: [-41.1, 5.4]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-46.5, 46.5]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.45495% CI: [-34.9, 13.5]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.06395% CI: [-44, -6]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.54495% CI: [-35.2, 55.2]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.66395% CI: [-25.5, 14.6]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.25195% CI: [-30.6, 0.6]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-13.4, 13]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-14.4, 18.7]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-18.7, 17.7]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 0.50195% CI: [-23.1, 3.1]Chi-squared
Secondary
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline or average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Subjects from ITT population with enhanced clinical response at Week 16. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 20 | 70.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 28 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 63.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 76.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 70.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 46.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 52 | 85.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 92.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 44 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 28 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 69.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 61.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 76.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 76.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 58.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 28 | 81.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 67.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 58.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 67.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 58.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 92.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 52 | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 64.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 58.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 44 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 71.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 20 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 28 | 55.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 36 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 44 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Responders, Week 52 | 44.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 57.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 57.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 57.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 57.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 42.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 46.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 46.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 46.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 50.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Clinical Responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16 | Non-responders, Week 28 | 100 percentage of participants |
Comparison: Responders, Week 20p-value: 0.15595% CI: [9.9, 50.1]Chi-squared
Comparison: Responders, Week 20p-value: 0.02495% CI: [9.9, 50.1]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-40.1, 33.4]Chi-squared
Comparison: Responders, Week 28p-value: 0.63395% CI: [-46.4, 29.2]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-24.7, 27.2]Chi-squared
Comparison: Responders, Week 28p-value: 0.20995% CI: [-61.3, 12.5]Chi-squared
Comparison: Responders, Week 36p-value: 0.28395% CI: [6, 44]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-28.5, 28.5]Chi-squared
Comparison: Responders, Week 36p-value: 0.04895% CI: [-77.8, -5.5]Chi-squared
Comparison: Responders, Week 44p-value: 0.40895% CI: [-18.6, 61.4]Chi-squared
Comparison: Responders, Week 44p-value: 0.12695% CI: [-5.5, 55.5]Chi-squared
Comparison: Responders, Week 44p-value: 0.45495% CI: [-54.5, 21.1]Chi-squared
Comparison: Responders, Week 52p-value: 0.18395% CI: [1.8, 69.7]Chi-squared
Comparison: Responders, Week 52p-value: 0.25795% CI: [-12.8, 50.3]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-44.7, 33.6]ANOVA
Comparison: Non-responders, Week 20p-value: 0.30795% CI: [-9.7, 76.3]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.17295% CI: [-4.1, 70.8]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-40.9, 55.1]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-27.8, 54.5]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.67595% CI: [-51.5, 28.1]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.64495% CI: [-59.2, 33.5]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-50.6, 50.6]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-33.4, 50]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-40.9, 55.1]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-50.6, 50.6]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-33.4, 50]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-40.9, 55.1]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-40.2, 60.2]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.39295% CI: [-22.9, 59.6]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-44.7, 50.5]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.0795% CI: [6.5, 51.5]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.00795% CI: [9.8, 49.2]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.82695% CI: [-26.1, 32.8]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-27.2, 27.7]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.64995% CI: [-27.8, 17.3]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.30495% CI: [-45.7, 12.4]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.7295% CI: [-18.2, 38.7]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.92395% CI: [-23, 25.4]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.19795% CI: [-50.4, 10.4]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.48695% CI: [-20.4, 43.5]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.16895% CI: [-7, 42.7]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.83395% CI: [-34.3, 27.6]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.17395% CI: [-8.2, 53.4]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.17895% CI: [-7.6, 42.8]Chi-squared
Comparison: Clinical responders, Week 52p-value: 195% CI: [-30.9, 30.9]ANCOVA
Secondary
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Enhanced endoscopic response was defined as SES-CD reduction from Induction Baseline \> 50% (or for an Induction Baseline SES-CD of 4, at least a 2 point reduction from Induction Baseline). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Responders | 40.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 15.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 28.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 28.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Responders | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Responders | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 11.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 44.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Responders | 30.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 36.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Responders | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 16.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 11.1 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 20.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Clinical responders | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52 | Non-responders | 25.0 percentage of participants |
Comparison: Respondersp-value: 0.69195% CI: [-30.8, 50.8]Chi-squared
Comparison: Respondersp-value: 0.08695% CI: [-2.5, 60]Chi-squared
Comparison: Respondersp-value: 0.70295% CI: [-45.6, 25.6]Chi-squared
Comparison: Non-respondersp-value: 0.55795% CI: [-24, -1]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-16.5, 15]Chi-squared
Comparison: Non-respondersp-value: 0.70795% CI: [-14.4, 24.2]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-27.9, 28.8]Chi-squared
Comparison: Clinical respondersp-value: 0.17595% CI: [-7.2, 40.6]Chi-squared
Comparison: Clinical respondersp-value: 0.51795% CI: [-18, 35.4]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-30.6, 0.6]Chi-squared
Comparison: Clinical non-respondersp-value: 0.66395% CI: [-25.5, 14.6]Chi-squared
Comparison: Clinical non-respondersp-value: 0.25195% CI: [-30.6, 0.6]Chi-squared
Secondary
Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an average daily stool frequency ≥ 4.0 or average daily abdominal pain ≥ 2.0 at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline | 12.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline | 15.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline | 30.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline | 26.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline | 36.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline | 18.8 percentage of participants |
p-value: 0.64795% CI: [-12.7, 20.5]Cochran-Mantel-Haenszel
p-value: 0.09395% CI: [-2.9, 37.1]Cochran-Mantel-Haenszel
p-value: 0.16595% CI: [-5.6, 32.8]Cochran-Mantel-Haenszel
p-value: 0.02395% CI: [3.4, 46.3]Cochran-Mantel-Haenszel
p-value: 0.44895% CI: [-11, 25]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than induction baseline AND average daily abdominal pain \<= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 52
Population: Participants from ITT population with isolated ileal Crohn's disease at Induction Baseline and daily stool frequency \>= 4.0 or daily abdominal pain \>=2.0 at Induction Baseline. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-100, -13.3]Chi-squared
Comparison: Non-respondersp-value: 0.2595% CI: [-20, 86.7]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-62.2, 95.6]Chi-squared
Comparison: Clinical respondersp-value: 0.595% CI: [-71.1, 4.4]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-71.1, 4.4]Chi-squared
Secondary
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively, and with modified clinical remission at Week 16 and daily stool frequency \>= 4.0 or daily abdominal pain \>= 2.0 at Induction Baseline. Non responder imputation. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 53.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 91.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 93.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 58.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 70.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 90.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 90.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 90.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 90.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 90.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 80.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 80.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 80.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 100 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 100 percentage of participants |
Comparison: Responders, Week 20p-value: 195% CI: [-57.2, 43.9]Chi-squared
Comparison: Responders, Week 20p-value: 0.32395% CI: [-9.2, 55.8]Chi-squared
Comparison: Responders, Week 20p-value: 0.51695% CI: [6.7, 60]Chi-squared
Comparison: Responders, Week 28p-value: 0.19195% CI: [-77.4, 14]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-26, 22.6]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-7.3, 24]Chi-squared
Comparison: Responders, Week 36p-value: 0.26195% CI: [6.7, 60]Chi-squared
Comparison: Responders, Week 36p-value: 0.32395% CI: [-9.2, 55.8]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-41.8, 58.5]Chi-squared
Comparison: Responders, Week 44p-value: 0.59395% CI: [-77.2, 23.9]Chi-squared
Comparison: Responders, Week 44p-value: 0.32395% CI: [-9.2, 55.8]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-41.8, 58.5]Chi-squared
Comparison: Responders, Week 52p-value: 0.695% CI: [-23.1, 66.5]Chi-squared
Comparison: Responders, Week 52p-value: 0.16295% CI: [-1.9, 65.2]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-34.1, 67.4]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-50.5, 77.2]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-100, 70.8]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.46495% CI: [-82.9, 2.9]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.495% CI: [-100, 19.3]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.46495% CI: [-100, 17.2]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-100, 70.8]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-95.1, 41.8]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-100, 70.8]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-77.2, 50.5]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-70.8, 100]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [13.3, 100]Chi-squared
Comparison: Clinical responders, Week 20p-value: 195% CI: [-33.8, 40.4]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.40895% CI: [-15.2, 48.5]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.26695% CI: [9.5, 57.2]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.12195% CI: [-66.2, -0.5]Chi-squared
Comparison: Clinical responders, Week 28p-value: -1095% CI: [-34.6, 14.6]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-6, 19.3]Chi-squared
Comparison: Clinical responders, Week 36p-value: 195% CI: [-45.3, 31.9]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.40895% CI: [-15.2, 48.5]Chi-squared
Comparison: Clinical responders, Week 36p-value: 195% CI: [-29.1, 55.7]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.24195% CI: [-65.3, 11.9]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.40895% CI: [-15.2, 48.5]Chi-squared
Comparison: Clinical responders, Week 44p-value: 195% CI: [-29.1, 55.7]Chi-squared
Comparison: Clinical responders, Week 52p-value: 195% CI: [-43.3, 36.6]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.21795% CI: [-2.9, 62.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.60395% CI: [-16.5, 69.9]Chi-squared
Secondary
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively, and with daily stool frequency \>= 4.0 or daily abdominal pain \>= 2.0 at Induction Baseline. Non responder imputation. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 41.2 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 5.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 46.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 39.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 70.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 58.8 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 11.8 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 47.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 5.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 21.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 7.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 47.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 28.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 17.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 5.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 5.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 57.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 44.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 11.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 22.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 64.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 57.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 35.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 87.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 11.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 37.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 44.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 57.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 73.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 9.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 4.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 48.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 48.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 6.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 51.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 73.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 73.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 48.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 6.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 51.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 12.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 12.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 15.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 38.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 30.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 10.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 15.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 10.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 15.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 44.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 28.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 80.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 42.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 42.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 57.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 42.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 37.5 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 20.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 37.5 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 52 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 28 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 28 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 44 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 36 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Non-responders, Week 20 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline | Clinical responders, Week 28 | 100 percentage of participants |
Comparison: Responders, Week 20p-value: 0.67395% CI: [-25.6, 56.5]Chi-squared
Comparison: Responders, Week 20p-value: 0.26595% CI: [-14, 53.3]Chi-squared
Comparison: Responders, Week 20p-value: 0.69595% CI: [-25.6, 51.5]Chi-squared
Comparison: Responders, Week 28p-value: 0.39495% CI: [-61.4, 20.3]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-36.1, 28.3]Chi-squared
Comparison: Responders, Week 28p-value: 0.68395% CI: [-47.9, 26.7]Chi-squared
Comparison: Responders, Week 36p-value: 0.20595% CI: [-4.1, 61.4]Chi-squared
Comparison: Responders, Week 36p-value: 0.38895% CI: [-17.9, 46.9]Chi-squared
Comparison: Responders, Week 36p-value: 0.23695% CI: [-65.6, 8]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-50.6, 31.5]Chi-squared
Comparison: Responders, Week 44p-value: 0.13195% CI: [-6.3, 58.9]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-45.6, 31.5]Chi-squared
Comparison: Responders, Week 52p-value: 0.41195% CI: [-19.6, 62.2]Chi-squared
Comparison: Responders, Week 52p-value: 0.06795% CI: [-0.2, 64.5]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-39.5, 37.2]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.17895% CI: [-8.8, 62]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.7295% CI: [-23.8, 12.3]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.68395% CI: [-27.2, 11.5]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.21595% CI: [-12.8, 58.9]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.27995% CI: [-30.4, 5.8]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.71695% CI: [-28.2, 15.4]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-27.5, 21.1]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.495% CI: [-23.5, 7.1]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-19.6, 21]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.6295% CI: [-22.2, 38]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.495% CI: [-23.5, 7.1]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-22.7, 14.2]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-18.7, 26.6]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.67895% CI: [-9.7, 19.6]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.63695% CI: [-10.5, 26.2]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.1995% CI: [-9.7, 52.5]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.50495% CI: [-17.3, 35.3]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.91695% CI: [-27.8, 31]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-31.7, 31.7]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.50495% CI: [-35.3, 17.3]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.63595% CI: [-36.6, 22.3]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.51395% CI: [-21.1, 42.5]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.89895% CI: [-24.7, 28.1]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.37995% CI: [-41.7, 15.5]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.82295% CI: [-34.5, 27.4]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.50895% CI: [-17.3, 35]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.68395% CI: [-34.3, 22.4]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.4995% CI: [-16.6, 45.1]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.07895% CI: [-1.9, 48.5]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.46695% CI: [-17.7, 38.4]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 195% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.44795% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 195% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-27.1, 3.6]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.19395% CI: [-27.1, 3.6]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 0.49895% CI: [-27.1, 3.6]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 195% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.44795% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 195% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 0.44795% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-17.1, 5.3]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-15.5, 13.3]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 195% CI: [-17.1, 5.3]Chi-squared
Secondary
Percentage of Participants Who Achieve Remission at Week 16
Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 16 | 2.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 16 | 5.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 16 | 2.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Remission at Week 16 | 8.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Remission at Week 16 | 5.7 percentage of participants |
p-value: 0.27695% CI: [-2.3, 8.1]Cochran-Mantel-Haenszel
p-value: 0.19595% CI: [-2.5, 12.4]Cochran-Mantel-Haenszel
p-value: 0.35595% CI: [-2.9, 8]Cochran-Mantel-Haenszel
p-value: 0.09995% CI: [-1.5, 16.8]Cochran-Mantel-Haenszel
p-value: 0.18595% CI: [-2.5, 12.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve Remission at Week 52
Remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. See definitions of responder and clinical responder in Outcome Measure 7 of this record.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 | Responders | 20.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 0.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Responders | 12.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 7.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Responders | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 13.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 4.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 2.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 15.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 0.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 0.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 0.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 0.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 | Non-Responders | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Non-Responders | 0.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 | Clinical Responders | 100 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-36.4, 21.4]Chi-squared
Comparison: Respondersp-value: 195% CI: [-22.5, 32.5]Chi-squared
Comparison: Respondersp-value: 0.27295% CI: [-37.5, -2.5]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-2.7, 8.6]Chi-squared
Comparison: Non-respondersp-value: 0.06895% CI: [-0.7, 26.8]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-23.1, 12.3]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-15.7, 18.3]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-16.7, 23.3]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-4.3, 13.9]Chi-squared
Secondary
Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline
Remission at Week 52 is defined as endoscopic remission at Week 52 AND clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Baseline, Week 52
Population: Participants from ITT population with isolated ileal Crohn's disease at Induction Baseline. Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical responders | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Responders | 50.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline | Non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-99, -1]Chi-squared
Comparison: Clinical Respondersp-value: 195% CI: [-55, 5]Chi-squared
Comparison: Clinical Respondersp-value: 195% CI: [-55, 5]Chi-squared
Comparison: Clinical Respondersp-value: 195% CI: [-55, 5]Chi-squared
Secondary
Percentage of Participants Who Achieve Response at Week 16
Response is defined as endoscopic response at Week 12/16 AND clinical response at Week 16. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Response at Week 16 | 2.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Response at Week 16 | 15.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Response at Week 16 | 32.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Response at Week 16 | 27.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Response at Week 16 | 38.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Response at Week 16 | 34.3 percentage of participants |
p-value: 0.0595% CI: [0, 26.5]Cochran-Mantel-Haenszel
p-value: 0.00195% CI: [11.9, 47.1]Cochran-Mantel-Haenszel
p-value: 0.00395% CI: [8.5, 42]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [17.6, 55.4]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [13.9, 50.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve Response at Week 52
Response at Week 52 was defined as both endoscopic response at Week 52 and clinical response at Week 52. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 34.4 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 5.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 6.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Achieve Response at Week 52 | Responders | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Responders | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 42.9 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 14.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Responders | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 51.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 4.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 13.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Responders | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 36.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Responders | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 16.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 22.2 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Response at Week 52 | Clinical responders | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Response at Week 52 | Non-responders | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants Who Achieve Response at Week 52 | Clinical non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 0.68695% CI: [-27.6, 52.6]Chi-squared
Comparison: Respondersp-value: 0.25795% CI: [-12.8, 50.3]Chi-squared
Comparison: Respondersp-value: 0.70995% CI: [-47.4, 27.4]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-16.6, 24.1]Chi-squared
Comparison: Non-respondersp-value: 0.42895% CI: [-6.1, 23]Chi-squared
Comparison: Non-respondersp-value: 0.63995% CI: [-9.3, 22.9]Chi-squared
Comparison: Clinical respondersp-value: 0.58395% CI: [-22.2, 39.2]Chi-squared
Comparison: Clinical respondersp-value: 0.17195% CI: [-7.2, 41.9]Chi-squared
Comparison: Clinical respondersp-value: 0.85995% CI: [-24.8, 29.7]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-13.4, 13]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-14.6, 4.6]Chi-squared
Secondary
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively, and in clinical remission at Week 16. Non responder imputation. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 76.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 53.8 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 76.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 76.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 90.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 84.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 83.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 57.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 66.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 55.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 55.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 52 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 44 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 36 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 52 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 44 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Clinical responders, Week 36 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction | Non-responders, Week 52 | 100 percentage of participants |
Comparison: Responders, Week 20p-value: 195% CI: [-72.2, 45.5]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-50.2, 33.1]Chi-squared
Comparison: Responders, Week 20p-value: 195% CI: [-4.8, 44.8]Chi-squared
Comparison: Responders, Week 28p-value: 0.42395% CI: [-79.8, 33.2]Chi-squared
Comparison: Responders, Week 28p-value: 0.2595% CI: [-74, 8.2]Chi-squared
Comparison: Responders, Week 28p-value: 195% CI: [-8.6, 28.6]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-4.8, 44.8]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-50.2, 33.1]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-72.2, 45.5]Chi-squared
Comparison: Responders, Week 44p-value: 0.20395% CI: [-100, 12.2]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-50.2, 33.1]Chi-squared
Comparison: Responders, Week 44p-value: 195% CI: [-72.2, 45.5]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-54.7, 68]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-33.8, 56.6]Chi-squared
Comparison: Responders, Week 52p-value: 195% CI: [-54.7, 68]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-100, 70.8]Chi-squared
Comparison: Non-responders, Week 20p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-100, 70.8]Chi-squared
Comparison: Non-responders, Week 28p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-100, 42.1]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-100, 70.8]Chi-squared
Comparison: Non-responders, Week 36p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-75.4, 75.4]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-100, 70.8]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-20, 86.7]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-75.4, 75.4]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [-86.7, 20]Chi-squared
Comparison: Non-responders, Week 52p-value: 195% CI: [13.3, 100]Chi-squared
Comparison: Clinical responders, Week 20p-value: 190% CI: [-31.2, 44]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.65595% CI: [-48.6, 28.1]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.54195% CI: [0.2, 46]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-37, 34.4]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.17895% CI: [-67, 8.9]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-4.2, 35]Chi-squared
Comparison: Clinical responders, Week 36p-value: 195% CI: [-54.4, 33.9]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.65595% CI: [-48.6, 28.1]Chi-squared
Comparison: Clinical responders, Week 36p-value: 195% CI: [-50.1, 46.3]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.3295% CI: [-73, 19.2]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.65595% CI: [-48.6, 28.1]Chi-squared
Comparison: Clinical responders, Week 44p-value: 195% CI: [-50.1, 46.3]Chi-squared
Comparison: Clinical responders, Week 52p-value: 195% CI: [-52.2, 44.5]Chi-squared
Comparison: Clinical responders, Week 52p-value: 195% CI: [-40.6, 44]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.60395% CI: [-29.2, 71.5]Chi-squared
Secondary
Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission and a score above 450 indicates very severe disease.
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16 | 27.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16 | 33.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16 | 40.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16 | 44.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16 | 55.6 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16 | 31.4 percentage of participants |
p-value: 0.60795% CI: [-15.5, 26.5]Cochran-Mantel-Haenszel
p-value: 0.27295% CI: [-9.6, 33.9]Cochran-Mantel-Haenszel
p-value: -0.15795% CI: [-6.1, 37.9]Cochran-Mantel-Haenszel
p-value: 0.01795% CI: [4.9, 50.6]Cochran-Mantel-Haenszel
p-value: 0.79895% CI: [-18.4, 23.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline.
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16 | 35.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16 | 46.2 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16 | 54.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16 | 44.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16 | 61.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16 | 48.6 percentage of participants |
p-value: 0.36395% CI: [-12, 32.9]Cochran-Mantel-Haenszel
p-value: 0.13795% CI: [-5.5, 40]Cochran-Mantel-Haenszel
p-value: 0.51295% CI: [-14.9, 29.9]Cochran-Mantel-Haenszel
p-value: 0.03595% CI: [-1.8, 48.2]Cochran-Mantel-Haenszel
p-value: 0.2995% CI: [-10.7, 35.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an average daily stool frequency ≥ 2.5 AND average daily abdominal pain ≥ 2.0 at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16 | 7.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16 | 17.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16 | 18.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16 | 16.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16 | 11.1 percentage of participants |
p-value: 0.42195% CI: [-14.4, 34.4]Cochran-Mantel-Haenszel
p-value: 0.37195% CI: [-13.8, 36.8]Cochran-Mantel-Haenszel
p-value: 0.44595% CI: [-14.4, 32.8]Cochran-Mantel-Haenszel
p-value: 0.19895% CI: [-10.2, 49.3]Cochran-Mantel-Haenszel
p-value: 0.65495% CI: [-17, 27]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline.
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Population: Non responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 46.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 20 | 80.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 46.9 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 12.5 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 56.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 15.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 28.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 35.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 52 | 55.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 65.6 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 44 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 28 | 85.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 34.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 40.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 52 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 85.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 20 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 70.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 28 | 62.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 30.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 36 | 100 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 44 | 87.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 25.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 60.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 71.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 50.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 44 | 81.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 26.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 58.6 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 36 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 89.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 26.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 29.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 62.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 29.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 23.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 62.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 72.4 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 28 | 68.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 19.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 14.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 52 | 75.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 47.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 20 | 93.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 63.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 36.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 20 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 28 | 60.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 36 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 42.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 34.8 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 57.9 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 26.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 17.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 7.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 30.4 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 14.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 7.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 75.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 37.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 66.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 83.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 33.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 25.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 40.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 33.3 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 22.2 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 40.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 25.0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 36 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 44 | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 52 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 28 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 44 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 36 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 28 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 28 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 52 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 20 | 50.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Non-responders, Week 44 | 25.0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 36 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 20 | 33.3 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical responders, Week 20 | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase | Clinical non-responders, Week 52 | 33.3 percentage of participants |
Comparison: Responders, Week 20p-value: 0.29595% CI: [2.5, 37.5]Chi-squared
Comparison: Responders, Week 20p-value: 0.35595% CI: [-7.4, 34.9]Chi-squared
Comparison: Responders, Week 20p-value: 0.38495% CI: [-55.1, 15.1]Chi-squared
Comparison: Responders, Week 28p-value: 0.31195% CI: [-59.5, 14.5]Chi-squared
Comparison: Responders, Week 28p-value: 0.42295% CI: [-43.8, 11.3]Chi-squared
Comparison: Responders, Week 28p-value: 0.18195% CI: [-59.2, 9.2]Chi-squared
Comparison: Responders, Week 36p-value: 0.28195% CI: [6, 44]Chi-squared
Comparison: Responders, Week 36p-value: 195% CI: [-28.5, 28.5]Chi-squared
Comparison: Responders, Week 36p-value: 0.23195% CI: [-61.3, 11.3]Chi-squared
Comparison: Responders, Week 44p-value: 0.21495% CI: [-3.9, 58.9]Chi-squared
Comparison: Responders, Week 44p-value: 0.27795% CI: [-7.5, 50]Chi-squared
Comparison: Responders, Week 44p-value: 0.44295% CI: [-57.2, 17.2]Chi-squared
Comparison: Responders, Week 52p-value: 0.41995% CI: [-17.1, 57.1]Chi-squared
Comparison: Responders, Week 52p-value: 0.21495% CI: [-10.4, 50.4]Chi-squared
Comparison: Responders, Week 52p-value: 0.43995% CI: [-52.4, 22.4]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.28495% CI: [-10.1, 56.4]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.98895% CI: [-23.9, 24.3]Chi-squared
Comparison: Non-responders, Week 20p-value: 0.3795% CI: [-38.1, 13.9]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.26895% CI: [-8.9, 60.2]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.66595% CI: [-27.4, 17.5]Chi-squared
Comparison: Non-responders, Week 28p-value: 0.75995% CI: [-28.9, 21]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.25995% CI: [-12.8, 56.6]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.8895% CI: [-23.2, 19.9]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.32995% CI: [-42.2, 13.9]Chi-squared
Comparison: Non-responders, Week 36p-value: 0.35595% CI: [-32.7, 11.2]Chi-squared
Comparison: Non-responders, Week 44p-value: 195% CI: [-27.1, 37.1]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.68895% CI: [-17, 25.9]Chi-squared
Comparison: Non-responders, Week 44p-value: 0.92795% CI: [-22.3, 24.5]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.07595% CI: [-5, 60]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.15495% CI: [-4.8, 32.7]Chi-squared
Comparison: Non-responders, Week 52p-value: 0.70795% CI: [-14.4, 24.2]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.08595% CI: [10, 40]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.13795% CI: [-4, 33.3]Chi-squared
Comparison: Clinical responders, Week 20p-value: 0.3795% CI: [-38.2, 14.5]Chi-squared
Comparison: Clinical responders, Week 28p-value: 195% CI: [-31.6, 24.4]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.17495% CI: [-39.8, 7]Chi-squared
Comparison: Clinical responders, Week 28p-value: 0.20395% CI: [-43.9, 9.7]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.28695% CI: [-4.5, 44.7]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.77395% CI: [-27.7, 20.6]Chi-squared
Comparison: Clinical responders, Week 36p-value: 0.10195% CI: [-51.2, 4.1]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.33295% CI: [-14.1, 44.4]Chi-squared
Comparison: Clinical responders, Week 44p-value: 0.18995% CI: [-7.5, 39.8]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.12495% CI: [-4.8, 53.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.23495% CI: [-9.5, 39.9]Chi-squared
Comparison: Clinical responders, Week 52p-value: 0.48495% CI: [-37.8, 17.7]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 195% CI: [-57.3, 37.3]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.43195% CI: [-38.9, 16.5]Chi-squared
Comparison: Clinical non-responders, Week 20p-value: 0.2595% CI: [-48.5, 7.1]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-40.9, 50.9]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-25.2, 23.3]Chi-squared
Comparison: Clinical non-responders, Week 28p-value: 195% CI: [-31.1, 19.6]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.54495% CI: [-35.2, 55.2]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 195% CI: [-22.4, 20.9]Chi-squared
Comparison: Clinical non-responders, Week 36p-value: 0.62795% CI: [-28.5, 12.8]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-18.7, 17.7]Chi-squared
Comparison: Clinical non-responders, Week 44p-value: 195% CI: [-18.3, 26.8]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 0.23295% CI: [-0.7, 29.3]Chi-squared
Comparison: Clinical non-responders, Week 52p-value: 0.41295% CI: [-6.3, 20.6]Chi-squared
Secondary
Percentage of Participants With Endoscopic Response at Week 12/16
Endoscopic response: SES-CD at least 25% reduction from Baseline. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Population: mITT Population: all randomized subjects who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Endoscopic Response at Week 12/16 | 13.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Endoscopic Response at Week 12/16 | 23.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Endoscopic Response at Week 12/16 | 43.2 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Endoscopic Response at Week 12/16 | 36.1 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Endoscopic Response at Week 12/16 | 50.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Endoscopic Response at Week 12/16 | 48.6 percentage of participants |
p-value: 0.24395% CI: [-7.2, 28.2]Cochran-Mantel-Haenszel
p-value: 0.00695% CI: [8.3, 49.9]Cochran-Mantel-Haenszel
p-value: 0.01795% CI: [4.4, 44.1]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [14.8, 58.1]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [15.2, 58.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16
Remission is defined as endoscopic remission AND clinical remission. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Time frame: Week 16
Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Only mITT participants with isolated ileal Crohn's disease at Baseline are included. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 | 0.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 | 20.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 | 16.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 | 20.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 | 0.0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16 | 20.0 percentage of participants |
p-value: 0.16795% CI: [-8.4, 48.4]Cochran-Mantel-Haenszel
p-value: 0.22195% CI: [-10, 43.3]Cochran-Mantel-Haenszel
p-value: 0.1895% CI: [-9.2, 49.2]Cochran-Mantel-Haenszel
p-value: 0.16795% CI: [-8.4, 48.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With SES-CD = 0 at Week 52
SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 6.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 3.1 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD = 0 at Week 52 | Responders | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 5.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 7.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Responders | 12.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 8.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 20.7 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Responders | 31.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 4.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 5.3 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With SES-CD = 0 at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With SES-CD = 0 at Week 52 | Clinical non-responders | 0 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-23.9, 28.9]Chi-squared
Comparison: Respondersp-value: 0.20495% CI: [-5, 47.5]Chi-squared
Comparison: Respondersp-value: 0.5495% CI: [-23.1, 3.1]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-9.2, 2.9]Chi-squared
Comparison: Non-respondersp-value: 0.61495% CI: [-5.6, 17]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-9.1, 11.5]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-15, 16.8]Chi-squared
Comparison: Clinical respondersp-value: 0.13595% CI: [-2.5, 31.4]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-14.1, 12.1]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-14.6, 4.6]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-11.3, 20.3]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-14.6, 4.6]Chi-squared
Secondary
Percentage of Participants With SES-CD ≤ 2 at Week 52
SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Time frame: Week 52
Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 6.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 6.3 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 10.0 percentage of participants |
| Double-Blind Induction Phase: Placebo BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Responders | 10.0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Responders | 12.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 3 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 7.1 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 9.5 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Responders | 31.3 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 8.8 percentage of participants |
| Double-Blind Induction Phase: Upadacitinib 6 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 20.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 8.7 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 10.5 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 12 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg BID | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Double Blind Induction Phase: Upadacitinib 24 mg QD | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 0 percentage of participants |
| Upadacitinib 12 mg BID in Extension/Placebo in Induction | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical responders | 100 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Clinical non-responders | 0 percentage of participants |
| Upadacitinib 24 mg QD in Extension/Placebo in Induction | Percentage of Participants With SES-CD ≤ 2 at Week 52 | Non-responders | 25.0 percentage of participants |
Comparison: Respondersp-value: 195% CI: [-23.9, 28.9]Chi-squared
Comparison: Respondersp-value: 0.20495% CI: [-5, 47.5]Chi-squared
Comparison: Respondersp-value: 0.5495% CI: [-23.1, 3.1]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-14.6, 2.1]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-10.1, 15.3]Chi-squared
Comparison: Non-respondersp-value: 195% CI: [-11.8, 16.7]Chi-squared
Comparison: Clinical respondersp-value: 195% CI: [-15, 16.8]Chi-squared
Comparison: Clinical respondersp-value: 0.13595% CI: [-2.5, 31.4]Chi-squared
Comparison: Clinical respondersp-value: 0.62395% CI: [-11.9, 20.4]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-23.1, 3.1]Chi-squared
Comparison: Clinical non-respondersp-value: 195% CI: [-18.7, 17.7]Chi-squared
Comparison: Clinical non-respondersp-value: 0.50195% CI: [-23.1, 3.1]Chi-squared