Ulcerative Colitis
Conditions
Keywords
ulcerative colitis, inflammatory bowel disease
Brief summary
This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.
Interventions
DRUGCP-690,500 5 mg
CP-690,550 5 mg tablet BID
DRUGCP-690,550 10 mg
CP-690,550 10 mg tablet BID
Sponsors
Pfizer
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively. * In stable remission on CP-690,550 10 mg BID * Agree to use highly effective contraception * Negative pregnancy test * Comply with visits, treatments, lab tests, diary and other study procedures * Signed and dated informed consent document.
Exclusion criteria
* Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy. * Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease * Likely to require surgery for ulcerative colitis during study * Expected to receive any prohibited medication * Expected to receive live or attenuated virus vaccination during study * Women who are pregnant or breastfeeding or planning to become pregnant during the study * Evidence of colonic malignancy or any dysplasia * Acute or chronic medical or psychiatric condition that may increase risk of participation * Investigator site staff member * Subjects likely to be uncooperative or unable to comply with study procedures * Participation in other studies involving investigational drugs during study * Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC: * has heart failure; * has inherited coagulation disorders; * has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism; * is taking combined hormonal contraceptives or hormone replacement therapy; * has malignancy (association is strongest with cancers other than non-melanoma skin cancers); * is undergoing major surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Remission Based on Modified Mayo Score at Month 6 | Month 6 | Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease. |
| Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Months 6, 18, 30 and 42 | Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease. |
| Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease. |
| Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42 | Months 18, 30 and 42 | Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease. |
| Change From Baseline in Modified Mayo Score at Month 6 | Baseline, Month 6 | Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease. |
| Change From Baseline in Modified Mayo Score at Months 18, 30 and 42 | Baseline, Months 18, 30 and 42 | Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease. |
| Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 | Baseline, Months 1, 3 and 6 | Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease. |
| Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease. |
| Change From Baseline in Total Mayo Score at Month 6 | Baseline, Month 6 | Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease. |
| Change From Baseline in Total Mayo Score at Months 18, 30 and 42 | Baseline, Months 18, 30 and 42 | Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease. |
| Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 | Baseline, Months 1, 3 and 6 | Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease. |
| Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method | Up to Month 42 | Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \>=1 point and increase in endoscopic subscore by \>=1 point; increase from Baseline in rectal bleeding subscore by \>=2 points and endoscopic subscore \>0; increase in stool frequency subscore by \>=2 points and increase in endoscopic subscore by \>=1 point; increase in endoscopic subscore by \>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease. |
| Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Months 6, 18, 30 and 42 | Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease. |
| Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Months 6, 18, 30 and 42 | Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease. |
| Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change from baseline in fecal calprotectin (in micrograms per gram \[mcg/g\]) was reported. |
| Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change From baseline in hs-CRP level (in milligrams per liter \[mg/L\]) is reported. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 43 months | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section). |
| Number of Participants With Serious Infections | Baseline up to 43 months | Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. |
| Number of Participants With Clinical Laboratory Abnormalities | Baseline up to 27 months | Abnormality criteria: Hematology: hemoglobin(Hg): \<0.8\* lower limit of normal (LLN); hematocrit: \<0.8\*LLN; lymphocytes: \<0.8\* LLN; lymphocytes/leukocytes: \<0.8\*LLN; erythrocytes: \<0.8\*LLN; erythrocytes mean corpuscular volume: \<0.9\*LLN; erythrocytes mean corpuscular Hg: \<0.9\*LLN; reticulocytes, reticulocytes/erythrocytes:\>1.5\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \>1.2\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \>1.2\*ULN; leukocyte esterase: \>=1; Clinical chemistry: bicarbonate:\<0.9\*LLN, bilirubin: \>1.5\*ULN; indirect bilirubin: \>1.5\* ULN; aspartate aminotransferase(AT): \>3.0\*ULN; alanine AT: \>3.0\*ULN; gamma glutamyl transferase: \>3.0\* ULN; creatine kinase: \>2.0\*ULN; potassium: \>1.1\*ULN; blood urea nitrogen: \>1.3\*ULN; creatinine: \>1.3\*ULN; urate: \>1.2\*ULN; cholesterol: \>1.3\*ULN; HDL-cholesterol: \<0.8\* LLN; LDL-cholesterol: \>1.2\*ULN; triglycerides: \>1.3\*ULN; glucose: \>1.5\*ULN; and urine Hg \>=1. |
| Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation | Baseline up to 43 months | Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \<750 neutrophils per cubic millimeter (mm\^3); 2 sequential lymphocyte counts \<500 lymphocytes/mm\^3; 2 sequential hemoglobin \<8.0 grams per deciliter; 2 sequential platelet counts \<75000 platelets/mm\^3; 2 sequential AST or ALT elevations \>=3\*ULN with at least one total bilirubin value \>=2\*ULN; 2 sequential AST or ALT elevations \>=3\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \>=5\*ULN; 2 sequential increases in creatinine \>50% and \>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \>10\*ULN unless the causality is known not to be medically serious (eg, exercise induced). |
| Number of Participants With Vital Sign Abnormalities | Baseline up to 43 months | Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \<50 millimeter of mercury (mmHg), b) change greater than equal to (\>=) 20 mmHg increase, c) change \>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \<90 mmHg, b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate \>120 bpm. Only those categories in which at least 1 participant had data were reported. |
| Number of Participants With Clinically Significant Physical Examinations Abnormalities | Baseline up to 43 months | Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator. |
| Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | Baseline up to 43 months | Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported. |
| Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease. |
Countries
Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The study enrolled participants from A3921139 (NCT01470612) who were on tofacitinib 10 milligram (mg) twice daily (BID) for at least 2 consecutive years, who were in stable remission for at least 6 months prior to baseline of A3921288 and who were not receiving any corticosteroid treatment to treat their ulcerative colitis (UC) for at least 4 weeks prior to enrollment.
Pre-assignment details
The Baseline visit of this study was the last visit in study A3921139. All procedures done at the last visit in A3921139 for participants enrolled into this study were used as the Baseline data for this study.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib 5 mg BID Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose. | 70 |
| Tofacitinib 10 mg BID Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose. | 70 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Phase (up to 4 Weeks) | Other | 2 | 1 |
| Treatment Phase (up to 42 Months) | Adverse Event | 10 | 10 |
| Treatment Phase (up to 42 Months) | Death | 0 | 1 |
| Treatment Phase (up to 42 Months) | Lack of Efficacy | 3 | 2 |
| Treatment Phase (up to 42 Months) | Other | 0 | 2 |
| Treatment Phase (up to 42 Months) | Pregnancy | 1 | 0 |
| Treatment Phase (up to 42 Months) | Study terminated by sponsor | 15 | 16 |
| Treatment Phase (up to 42 Months) | Withdrawal by Subject | 5 | 12 |
Baseline characteristics
| Characteristic | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 7 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 63 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 67 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) White | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 26 Participants | 22 Participants | 48 Participants |
| Sex: Female, Male Male | 44 Participants | 48 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 1 / 70 |
| other Total, other adverse events | 47 / 70 | 47 / 70 |
| serious Total, serious adverse events | 7 / 70 | 16 / 70 |
Outcome results
Primary
Number of Participants With Remission Based on Modified Mayo Score at Month 6
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
Time frame: Month 6
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Month 6 | 54 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Month 6 | 63 Participants |
Comparison: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [0.5, 25]
Secondary
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change from baseline in fecal calprotectin (in micrograms per gram \[mcg/g\]) was reported.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | -28.8 Micrograms per gram | Standard Deviation 1113.4 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | 118.3 Micrograms per gram | Standard Deviation 1591.4 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 3 | -45.3 Micrograms per gram | Standard Deviation 1075.8 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | 87.3 Micrograms per gram | Standard Deviation 478.8 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | -104.8 Micrograms per gram | Standard Deviation 1210.2 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | -8.5 Micrograms per gram | Standard Deviation 458.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | -173.5 Micrograms per gram | Standard Deviation 1106.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | 84.4 Micrograms per gram | Standard Deviation 434.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | -51.0 Micrograms per gram | Standard Deviation 1114.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | 230.7 Micrograms per gram | Standard Deviation 1162.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 6 | -24.1 Micrograms per gram | Standard Deviation 1444.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | -116.2 Micrograms per gram | Standard Deviation 472.8 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | -71.0 Micrograms per gram | Standard Deviation 1254.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | -44.7 Micrograms per gram | Standard Deviation 278.9 |
| Tofacitinib 5 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 1 | -137.5 Micrograms per gram | Standard Deviation 980.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | -101.0 Micrograms per gram | Standard Deviation 452 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 1 | -21.9 Micrograms per gram | Standard Deviation 304.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 3 | -38.5 Micrograms per gram | Standard Deviation 313.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 6 | -47.3 Micrograms per gram | Standard Deviation 331.4 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | -59.3 Micrograms per gram | Standard Deviation 380.8 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | -45.0 Micrograms per gram | Standard Deviation 350.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | 69.3 Micrograms per gram | Standard Deviation 480.5 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | 6.6 Micrograms per gram | Standard Deviation 565.4 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | -29.3 Micrograms per gram | Standard Deviation 462.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | -69.8 Micrograms per gram | Standard Deviation 407 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | -49.1 Micrograms per gram | Standard Deviation 366.3 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | -8.9 Micrograms per gram | Standard Deviation 518.5 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | -4.9 Micrograms per gram | Standard Deviation 484.8 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | -0.4 Micrograms per gram | Standard Deviation 449.4 |
| Tofacitinib 10 mg BID | Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | -98.3 Micrograms per gram | Standard Deviation 532.9 |
Secondary
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change From baseline in hs-CRP level (in milligrams per liter \[mg/L\]) is reported.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | -0.5 Milligrams per liter | Standard Deviation 3.3 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 1 | 1.1 Milligrams per liter | Standard Deviation 9.8 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | -0.6 Milligrams per liter | Standard Deviation 3 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | -0.3 Milligrams per liter | Standard Deviation 3.5 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | -0.3 Milligrams per liter | Standard Deviation 2.8 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 6 | 0.9 Milligrams per liter | Standard Deviation 5.8 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | 0.6 Milligrams per liter | Standard Deviation 4.1 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | -0.7 Milligrams per liter | Standard Deviation 3.2 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | 0.1 Milligrams per liter | Standard Deviation 2.2 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 3 | 0.7 Milligrams per liter | Standard Deviation 7.9 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | -0.1 Milligrams per liter | Standard Deviation 3.1 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | -0.3 Milligrams per liter | Standard Deviation 3.5 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | 1.0 Milligrams per liter | Standard Deviation 6.4 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | 0.6 Milligrams per liter | Standard Deviation 3.7 |
| Tofacitinib 5 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | 0.7 Milligrams per liter | Standard Deviation 11.1 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | 5.9 Milligrams per liter | Standard Deviation 28.1 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 1 | -0.7 Milligrams per liter | Standard Deviation 3.4 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 3 | -0.2 Milligrams per liter | Standard Deviation 3.7 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 6 | 0.1 Milligrams per liter | Standard Deviation 4 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | 1.1 Milligrams per liter | Standard Deviation 8.4 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | -0.2 Milligrams per liter | Standard Deviation 2.2 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | 0.2 Milligrams per liter | Standard Deviation 2.4 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | 0.2 Milligrams per liter | Standard Deviation 1.9 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | -0.1 Milligrams per liter | Standard Deviation 1.4 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | -0.5 Milligrams per liter | Standard Deviation 2.2 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | 0.7 Milligrams per liter | Standard Deviation 6.1 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | -0.3 Milligrams per liter | Standard Deviation 1.9 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | 0.0 Milligrams per liter | Standard Deviation 3.9 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | 2.8 Milligrams per liter | Standard Deviation 8.6 |
| Tofacitinib 10 mg BID | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | -0.1 Milligrams per liter | Standard Deviation 3.9 |
Secondary
Change From Baseline in Modified Mayo Score at Month 6
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
Time frame: Baseline, Month 6
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Modified Mayo Score at Month 6 | 0.6 Units on a scale | Standard Error 0.2 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Mayo Score at Month 6 | 0.3 Units on a scale | Standard Error 0.2 |
95% CI: [-0.8, 0.1]
Secondary
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
Time frame: Baseline, Months 18, 30 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Modified Mayo Score at Months 18, 30 and 42 | Change at Month 18 | 0.5 Units on a scale | Standard Deviation 1.3 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Mayo Score at Months 18, 30 and 42 | Change at Month 30 | 0.3 Units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Mayo Score at Months 18, 30 and 42 | Change at Month 42 | 0.3 Units on a scale | Standard Deviation 0.9 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Mayo Score at Months 18, 30 and 42 | Change at Month 18 | 0.3 Units on a scale | Standard Deviation 1.5 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Mayo Score at Months 18, 30 and 42 | Change at Month 30 | 0.1 Units on a scale | Standard Deviation 0.9 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Mayo Score at Months 18, 30 and 42 | Change at Month 42 | 0.2 Units on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 1, 3 and 6
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 | Change at Month 1 | 0.1 Units on a scale | Standard Error 0.1 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 | Change at Month 3 | 0.2 Units on a scale | Standard Error 0.1 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 | Change at Month 6 | 0.1 Units on a scale | Standard Error 0.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 | Change at Month 1 | 0.2 Units on a scale | Standard Error 0.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 | Change at Month 3 | 0.1 Units on a scale | Standard Error 0.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 | Change at Month 6 | 0.2 Units on a scale | Standard Error 0.1 |
Comparison: Month 195% CI: [-0.1, 0.3]
Comparison: Month 395% CI: [-0.2, 0.2]
Comparison: Month 695% CI: [-0.2, 0.3]
Secondary
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | 0.1 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | 0.1 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | 0.1 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | 0.1 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | 0.0 Units on a scale | Standard Deviation 0.4 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | 0.1 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | 0.0 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | 0.2 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | 0.0 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | 0.0 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | 0.1 Units on a scale | Standard Deviation 0.4 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | 0.1 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | 0.1 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | 0.1 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | 0.2 Units on a scale | Standard Deviation 1.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | 0.0 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | 0.1 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | 0.0 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | 0.2 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | 0.0 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 10 mg BID | Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | 0.0 Units on a scale | Standard Deviation 0.5 |
Secondary
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 1, 3 and 6
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 | Change at Month 1 | 0.2 Units on a scale | Standard Error 0.1 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 | Change at Month 3 | 0.3 Units on a scale | Standard Error 0.1 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 | Change at Month 6 | 0.3 Units on a scale | Standard Error 0.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 | Change at Month 1 | 0.2 Units on a scale | Standard Error 0.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 | Change at Month 3 | 0.2 Units on a scale | Standard Error 0.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 | Change at Month 6 | 0.3 Units on a scale | Standard Error 0.1 |
Comparison: Month 195% CI: [-0.3, 0.3]
Comparison: Month 395% CI: [-0.3, 0.2]
Comparison: Month 695% CI: [-0.3, 0.3]
Secondary
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | 0.2 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | 0.1 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | 0.3 Units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | 0.2 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | 0.1 Units on a scale | Standard Deviation 0.7 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | 0.2 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | 0.0 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | 0.0 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 5 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | 0.1 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 39 | -0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 9 | 0.2 Units on a scale | Standard Deviation 0.9 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 27 | 0.1 Units on a scale | Standard Deviation 0.9 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 12 | 0.2 Units on a scale | Standard Deviation 0.9 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 36 | -0.1 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 15 | 0.1 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 30 | 0.1 Units on a scale | Standard Deviation 0.8 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 18 | 0.2 Units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 42 | 0.2 Units on a scale | Standard Deviation 1.1 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 21 | 0.4 Units on a scale | Standard Deviation 1.7 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 33 | 0.2 Units on a scale | Standard Deviation 1 |
| Tofacitinib 10 mg BID | Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Change at Month 24 | 0.0 Units on a scale | Standard Deviation 0.8 |
Secondary
Change From Baseline in Total Mayo Score at Month 6
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Baseline, Month 6
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Total Mayo Score at Month 6 | 0.9 Units on a scale | Standard Error 0.2 |
| Tofacitinib 10 mg BID | Change From Baseline in Total Mayo Score at Month 6 | 0.4 Units on a scale | Standard Error 0.3 |
95% CI: [-1.2, 0.1]
Secondary
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Baseline, Months 18, 30 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed= participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Total Mayo Score at Months 18, 30 and 42 | Change at Month 18 | 0.7 Units on a scale | Standard Deviation 1.7 |
| Tofacitinib 5 mg BID | Change From Baseline in Total Mayo Score at Months 18, 30 and 42 | Change at Month 30 | 0.4 Units on a scale | Standard Deviation 1.4 |
| Tofacitinib 5 mg BID | Change From Baseline in Total Mayo Score at Months 18, 30 and 42 | Change at Month 42 | 0.4 Units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg BID | Change From Baseline in Total Mayo Score at Months 18, 30 and 42 | Change at Month 18 | 0.4 Units on a scale | Standard Deviation 1.9 |
| Tofacitinib 10 mg BID | Change From Baseline in Total Mayo Score at Months 18, 30 and 42 | Change at Month 30 | 0.1 Units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg BID | Change From Baseline in Total Mayo Score at Months 18, 30 and 42 | Change at Month 42 | 0.2 Units on a scale | Standard Deviation 1.4 |
Secondary
Number of Participants With Clinical Laboratory Abnormalities
Abnormality criteria: Hematology: hemoglobin(Hg): \<0.8\* lower limit of normal (LLN); hematocrit: \<0.8\*LLN; lymphocytes: \<0.8\* LLN; lymphocytes/leukocytes: \<0.8\*LLN; erythrocytes: \<0.8\*LLN; erythrocytes mean corpuscular volume: \<0.9\*LLN; erythrocytes mean corpuscular Hg: \<0.9\*LLN; reticulocytes, reticulocytes/erythrocytes:\>1.5\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \>1.2\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \>1.2\*ULN; leukocyte esterase: \>=1; Clinical chemistry: bicarbonate:\<0.9\*LLN, bilirubin: \>1.5\*ULN; indirect bilirubin: \>1.5\* ULN; aspartate aminotransferase(AT): \>3.0\*ULN; alanine AT: \>3.0\*ULN; gamma glutamyl transferase: \>3.0\* ULN; creatine kinase: \>2.0\*ULN; potassium: \>1.1\*ULN; blood urea nitrogen: \>1.3\*ULN; creatinine: \>1.3\*ULN; urate: \>1.2\*ULN; cholesterol: \>1.3\*ULN; HDL-cholesterol: \<0.8\* LLN; LDL-cholesterol: \>1.2\*ULN; triglycerides: \>1.3\*ULN; glucose: \>1.5\*ULN; and urine Hg \>=1.
Time frame: Baseline up to 27 months
Population: Safety analysis set included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Clinical Laboratory Abnormalities | 33 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Clinical Laboratory Abnormalities | 51 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \<750 neutrophils per cubic millimeter (mm\^3); 2 sequential lymphocyte counts \<500 lymphocytes/mm\^3; 2 sequential hemoglobin \<8.0 grams per deciliter; 2 sequential platelet counts \<75000 platelets/mm\^3; 2 sequential AST or ALT elevations \>=3\*ULN with at least one total bilirubin value \>=2\*ULN; 2 sequential AST or ALT elevations \>=3\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \>=5\*ULN; 2 sequential increases in creatinine \>50% and \>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \>10\*ULN unless the causality is known not to be medically serious (eg, exercise induced).
Time frame: Baseline up to 43 months
Population: Safety analysis set included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation | 1 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation | 1 Participants |
Secondary
Number of Participants With Clinically Significant Physical Examinations Abnormalities
Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.
Time frame: Baseline up to 43 months
Population: Safety analysis set included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Clinically Significant Physical Examinations Abnormalities | 28 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Clinically Significant Physical Examinations Abnormalities | 27 Participants |
Secondary
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Months 6, 18, 30 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 6 | 59 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 18 | 42 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 30 | 41 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 42 | 26 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 42 | 28 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 6 | 67 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 30 | 48 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42 | Month 18 | 50 Participants |
Comparison: Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [1.3, 22]
Comparison: Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-4.2, 26.4]
Comparison: Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-5.8, 25.2]
Comparison: Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-13, 18.5]
Secondary
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.
Time frame: Months 6, 18, 30 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 6 | 56 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 18 | 43 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 30 | 38 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 42 | 36 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 42 | 36 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 6 | 64 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 30 | 47 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42 | Month 18 | 56 Participants |
Comparison: Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-0.3, 23.1]
Comparison: Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [3.5, 32.6]
Comparison: Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-3.3, 28.1]
Comparison: Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-16.1, 16.1]
Secondary
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.
Time frame: Baseline up to 43 months
Population: Safety analysis set included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | Opportunistic Infections | 0 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | All Malignancy | 4 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | Gastrointestinal Perforation | 0 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | Cardiovascular Events | 2 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | Cardiovascular Events | 2 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | Opportunistic Infections | 1 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | Gastrointestinal Perforation | 0 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee | All Malignancy | 3 Participants |
Secondary
Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
Time frame: Months 18, 30 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42 | Month 18 | 37 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42 | Month 30 | 35 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42 | Month 42 | 23 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42 | Month 18 | 48 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42 | Month 30 | 44 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42 | Month 42 | 24 Participants |
Comparison: Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-0.4, 30.8]
Comparison: Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-3.5, 28.3]
Comparison: Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-14, 16.7]
Secondary
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.
Time frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 12 | 50 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 24 | 47 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 3 | 57 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 27 | 43 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 15 | 48 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 30 | 44 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 9 | 52 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 33 | 42 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 18 | 45 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 36 | 42 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 6 | 57 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 39 | 40 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 21 | 46 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 42 | 26 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 1 | 62 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 42 | 29 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 1 | 64 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 3 | 65 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 6 | 67 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 9 | 66 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 12 | 61 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 15 | 58 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 18 | 55 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 21 | 51 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 24 | 51 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 27 | 49 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 30 | 46 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 33 | 43 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 36 | 44 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 39 | 37 Participants |
Comparison: Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-7.5, 13.4]
Comparison: Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [0.1, 22.8]
Comparison: Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [2.9, 25.2]
Comparison: Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [8, 31.8]
Comparison: Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [2.2, 28.7]
Comparison: Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [0, 27.9]
Comparison: Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-0.7, 28.5]
Comparison: Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-8, 21.9]
Comparison: Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-9.3, 20.4]
Comparison: Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-7, 23.6]
Comparison: Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-12.8, 18.3]
Comparison: Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-14.4, 17.2]
Comparison: Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-13, 18.5]
Comparison: Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-20.2, 11.9]
Comparison: Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-11.7, 19.9]
Secondary
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Time frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 12 | 50 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 24 | 46 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 3 | 57 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 27 | 42 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 15 | 48 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 30 | 43 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 9 | 52 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 33 | 42 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 18 | 44 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 36 | 42 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 6 | 56 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 39 | 39 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 21 | 46 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 42 | 26 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 1 | 62 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 42 | 28 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 1 | 64 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 3 | 65 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 6 | 66 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 9 | 66 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 12 | 61 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 15 | 58 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 18 | 55 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 21 | 50 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 24 | 51 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 27 | 49 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 30 | 46 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 33 | 43 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 36 | 44 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | Month 39 | 37 Participants |
Comparison: Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-7.5, 13.4]
Comparison: Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [0.1, 22.8]
Comparison: Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [2.4, 25.6]
Comparison: Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [8, 31.8]
Comparison: Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [2.2, 28.7]
Comparison: Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [0, 27.9]
Comparison: Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [0.7, 29.9]
Comparison: Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-9.5, 20.6]
Comparison: Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-8, 21.9]
Comparison: Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-5.7, 25.1]
Comparison: Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-11.4, 19.7]
Comparison: Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-14.4, 17.2]
Comparison: Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-13, 18.5]
Comparison: Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-18.8, 13.3]
Comparison: Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-13, 18.5]
Secondary
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Months 6, 18, 30 and 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 6 | 53 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 18 | 33 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 30 | 35 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 42 | 22 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 42 | 24 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 6 | 61 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 30 | 44 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42 | Month 18 | 47 Participants |
Comparison: Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-1.5, 24.1]
Comparison: Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [3.6, 35]
Comparison: Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-3.5, 28.3]
Comparison: Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.95% CI: [-12.5, 18]
Secondary
Number of Participants With Serious Infections
Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.
Time frame: Baseline up to 43 months
Population: Safety analysis set included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Serious Infections | 3 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Serious Infections | 6 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).
Time frame: Baseline up to 43 months
Population: Safety analysis set included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 55 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 58 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 16 Participants |
Secondary
Number of Participants With Vital Sign Abnormalities
Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \<50 millimeter of mercury (mmHg), b) change greater than equal to (\>=) 20 mmHg increase, c) change \>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \<90 mmHg, b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate \>120 bpm. Only those categories in which at least 1 participant had data were reported.
Time frame: Baseline up to 43 months
Population: Safety analysis set included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Number of Participants With Vital Sign Abnormalities | SBP: <90mmHg | 2 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Vital Sign Abnormalities | DBP: Change >= 20mmHg increase | 9 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Vital Sign Abnormalities | SBP: Change >= 30mmHg increase | 7 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Vital Sign Abnormalities | DBP: Change >= 20mmHg decrease | 7 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Vital Sign Abnormalities | SBP: Change >= 30mmHg decrease | 6 Participants |
| Tofacitinib 5 mg BID | Number of Participants With Vital Sign Abnormalities | DBP: <50 mmHg | 3 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Vital Sign Abnormalities | SBP: Change >= 30mmHg decrease | 6 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Vital Sign Abnormalities | DBP: <50 mmHg | 0 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Vital Sign Abnormalities | DBP: Change >= 20mmHg decrease | 7 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Vital Sign Abnormalities | SBP: <90mmHg | 0 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Vital Sign Abnormalities | SBP: Change >= 30mmHg increase | 4 Participants |
| Tofacitinib 10 mg BID | Number of Participants With Vital Sign Abnormalities | DBP: Change >= 20mmHg increase | 5 Participants |
Secondary
Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \>=1 point and increase in endoscopic subscore by \>=1 point; increase from Baseline in rectal bleeding subscore by \>=2 points and endoscopic subscore \>0; increase in stool frequency subscore by \>=2 points and increase in endoscopic subscore by \>=1 point; increase in endoscopic subscore by \>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.
Time frame: Up to Month 42
Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib 5 mg BID | Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method | NA Days |
| Tofacitinib 10 mg BID | Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method | 1270 Days |