Ulcerative Colitis
Conditions
Keywords
Adalimumab trough level, Fecal Calprotectin, Fecal microbiota
Brief summary
This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants will have one Follow-up for safety approximately 70 days after the last dose of adalimumab.
Detailed description
This is a prospective, single-country, multi-center study in UC patients treated with adalimumab. The prescription of adalimumab is at the discretion of the physician in accordance with clinical practice and label, is made independently from this study, and preceded the decision to offer the patient the opportunity to participate in this study. Up to 147 subjects are planned to be enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Participants are administered adalimumab 160 mg at Week 0, 80 mg at Week 2, and then 40 mg every other week per the Korean label. Study visits are conducted at Weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants had one Follow-up for safety approximately 70 days after the last dose of adalimumab. Clinical response is assessed at Week 8, and participants with clinical response at Week 8 can continue on adalimumab treatment as per Korean reimbursement guidelines. Clinical response is defined as a decrease from baseline in the total Mayo score by at least 3 points and at least 30% with an accompanying decrease in rectal bleeding subscore of at least 1 point or absolute rectal bleeding sub-score of 0 or 1.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be an adult ≥19 years * Participant with active moderate to severe ulcerative colitis with Mayo score of ≥ 6 points and endoscopic sub-score of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants. * Participant must have tuberculosis (TB) Screening Assessment in accordance Korean reimbursement guidelines. * Participants who had started on adalimumab treatment in normal clinical practice setting by their physician. * Participant must provide written authorization form to use personal and/or health data prior to the entry into the study.
Exclusion criteria
* Female participants who are pregnant or breast feeding * Participant with any contraindication to adalimumab * Participant that is participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56 | Week 56 | Durable clinical response was defined as reduction in complete Full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Week 8 and 56. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants With Clinical Response at Week 8 | Week 8 | Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants With Clinical Response at Week 24 | Week 24 | Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 24. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants With Clinical Response at Week 56 | Week 56 | Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Steroid-free Remission at Week 8 | Week 8 | Steroid free remission was defined as participants who were in remission without the use of systemic steroids from Visit 1 (Baseline) prior to assessment. |
| Percentage of Participants With Steroid-free Remission at Week 56 | Week 56 | Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. |
| Percentage of Participants With Clinical Remission at Week 8 | Week 8 | Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants With Clinical Remission at Week 56 | Week 56 | Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8 | Week 8 | Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56 | Week 56 | Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8 | Week 8 | Steroid-free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56 | Week 56 | Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants With Steroid-free Response at Week 8 | Week 8 | Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants With Steroid-free Response at Week 56 | Week 56 | Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8 | Week 8 | Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment (in Week 8 clinical responders).Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56 | Week 56 | Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 12 weeks prior to assessment (in Week 8 clinical responders). A participant was a Week 8 responder if they had a clinical response at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Percentage of Participants With Mucosal Healing at Week 8 | Week 8 | Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at week 8. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease. |
| Percentage of Participants With Mucosal Healing at Week 56 | Week 56 | Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease. |
| Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8 | Week 8 | Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 8. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement. |
| Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56 | Week 56 | Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement. |
| Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56 | Baseline, Week 8 | The partial Mayo score is based on the Mayo score, which is a tool designed to measure disease activity for ulcerative colitis. The partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in partial Mayo score indicates improvement. |
| Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56 | Baseline, Week 8 | Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56 | Baseline, Week 56 | Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Fecal Calprotectin Level at Week 8 | Week 8 | Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. |
| Fecal Calprotectin Level at Week 56 | Week 56 | Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. |
| Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8 | Week 8 | Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. |
| Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8 | Week 56 | Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. |
| Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56 | Week 8 | Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56 | Week 56 | Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. |
| Change in the Composition of Fecal Microbiota From Baseline to Week 8 and Week 56 | Week 0, Week 8, Week 56 | Composition of fecal microbiota (16S ribosomal ribonucleic acid (rRNA) gene sequencing) was measured at Week 0, Week 8, and Week 56. Fecal bacterial composition was determined using 16S sequencing. The obtained sequences were analyzed using the Ezbiocloud database and 16S microbiome pipeline to assess composition and diversity. |
Countries
South Korea
Participant flow
Pre-assignment details
There were 150 participants enrolled; 4 were not treated and hence 146 were included in the intent to treat (ITT) set.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label. | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Events/Serious Adverse Events | 11 |
| Overall Study | investigator's judgment | 12 |
| Overall Study | Lack of Efficacy | 22 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Participant's decision | 3 |
| Overall Study | Participant's withdrawal of consent | 4 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | Adalimumab | — |
|---|---|---|
| Age, Continuous | 44.96 years STANDARD_DEVIATION 14.91 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 96 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 146 |
| other Total, other adverse events | 5 / 146 |
| serious Total, serious adverse events | 9 / 146 |
Outcome results
Primary
Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56
Durable clinical response was defined as reduction in complete Full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Week 8 and 56. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set: all participants that were intended to be treated with adalimumab. At Week 8, all participants who had received adalimumab treatment at least once were included and at Week 56, all participants who had clinical response at Week 8 were included. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56 | 53.95 percentage of participants |
Primary
Percentage of Participants With Clinical Response at Week 24
Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 24. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 24
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Clinical Response at Week 24 | 54.11 percentage of participants |
Primary
Percentage of Participants With Clinical Response at Week 56
Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Clinical Response at Week 56 | 37.67 percentage of participants |
Primary
Percentage of Participants With Clinical Response at Week 8
Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set: all participants that were intended to be treated with adalimumab. At Week 8, all participants who had received adalimumab treatment at least once were included and at Week 56, all participants who had clinical response at Week 8 were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Clinical Response at Week 8 | 52.05 percentage of participants |
Secondary
Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Baseline, Week 56
Population: ITT set of participants who were clinical responders at Week 56
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56 | 2.38 score on a scale | Standard Deviation 2.06 |
Secondary
Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Baseline, Week 8
Population: ITT set of participants who were clinical responders at Week 56 with evaluable data for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56 | 3.17 score on a scale | Standard Deviation 2.29 |
Secondary
Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56
The partial Mayo score is based on the Mayo score, which is a tool designed to measure disease activity for ulcerative colitis. The partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in partial Mayo score indicates improvement.
Time frame: Baseline, Week 8
Population: ITT set of participants who were clinical responders at Week 56
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56 | 1.89 score on a scale | Standard Deviation 1.61 |
Secondary
Change in the Composition of Fecal Microbiota From Baseline to Week 8 and Week 56
Composition of fecal microbiota (16S ribosomal ribonucleic acid (rRNA) gene sequencing) was measured at Week 0, Week 8, and Week 56. Fecal bacterial composition was determined using 16S sequencing. The obtained sequences were analyzed using the Ezbiocloud database and 16S microbiome pipeline to assess composition and diversity.
Time frame: Week 0, Week 8, Week 56
Population: This endpoint was not completed due to lack of data collection.
Secondary
Fecal Calprotectin Level at Week 56
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Time frame: Week 56
Population: ITT set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Fecal Calprotectin Level at Week 56 | 380.17 mg/kg | Standard Deviation 466.93 |
Secondary
Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set of participants who were clinical responders at Week 56 and had evaluable data for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56 | 415.40 mg/kg | Standard Deviation 490.94 |
Secondary
Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Time frame: Week 56
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8 | 281.87 mg/kg | Standard Deviation 375.15 |
Secondary
Fecal Calprotectin Level at Week 8
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Time frame: Week 8
Population: ITT set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Fecal Calprotectin Level at Week 8 | 456.89 mg/kg | Standard Deviation 480.65 |
Secondary
Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56 | 464.58 mg/kg | Standard Deviation 511.81 |
Secondary
Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Time frame: Week 8
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab | Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8 | 336.33 mg/kg | Standard Deviation 450.33 |
Secondary
Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56
Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56 | 35.53 percentage of participants |
Secondary
Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8
Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8 | 23.97 percentage of participants |
Secondary
Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56
Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56 | 46.05 percentage of participants |
Secondary
Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8
Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 8. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8 | 39.04 percentage of participants |
Secondary
Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56
Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56 | 34.21 percentage of participants |
Secondary
Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8
Steroid-free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8 | 12.33 percentage of participants |
Secondary
Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56
Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 12 weeks prior to assessment (in Week 8 clinical responders). A participant was a Week 8 responder if they had a clinical response at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56 | 51.32 percentage of participants |
Secondary
Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8
Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment (in Week 8 clinical responders).Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8 | 30.82 percentage of participants |
Secondary
Percentage of Participants With Clinical Remission at Week 56
Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Clinical Remission at Week 56 | 21.92 percentage of participants |
Secondary
Percentage of Participants With Clinical Remission at Week 8
Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Clinical Remission at Week 8 | 23.97 percentage of participants |
Secondary
Percentage of Participants With Mucosal Healing at Week 56
Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease.
Time frame: Week 56
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Mucosal Healing at Week 56 | 30.14 percentage of participants |
Secondary
Percentage of Participants With Mucosal Healing at Week 8
Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at week 8. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease.
Time frame: Week 8
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Mucosal Healing at Week 8 | 39.04 percentage of participants |
Secondary
Percentage of Participants With Steroid-free Remission at Week 56
Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment.
Time frame: Week 56
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Steroid-free Remission at Week 56 | 21.23 percentage of participants |
Secondary
Percentage of Participants With Steroid-free Remission at Week 8
Steroid free remission was defined as participants who were in remission without the use of systemic steroids from Visit 1 (Baseline) prior to assessment.
Time frame: Week 8
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Steroid-free Remission at Week 8 | 12.33 percentage of participants |
Secondary
Percentage of Participants With Steroid-free Response at Week 56
Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 56
Population: ITT set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Steroid-free Response at Week 56 | 36.30 percentage of participants |
Secondary
Percentage of Participants With Steroid-free Response at Week 8
Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Time frame: Week 8
Population: ITT set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants With Steroid-free Response at Week 8 | 30.82 percentage of participants |