Trial Outcomes & Findings for A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis (NCT NCT01458951)
NCT ID: NCT01458951
Last Updated: 2016-06-01
Results Overview
Remission in participants 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 Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
547 participants
Primary outcome timeframe
Week 8
Results posted on
2016-06-01
Participant Flow
Participants were randomized to tofacitinib 10 milligram (mg) or placebo twice a day (BID)(4:1 ratio) after Protocol Amendment 2, which removed tofacitinib 15 mg BID. Due to low participant numbers, tofacitinib 15 mg BID was excluded from efficacy analyses, but was included in participant flow, baseline characteristics and adverse events analyses.
Participant milestones
| Measure |
Tofacitinib 10 mg BID
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Tofacitinib 15 mg BID
Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
429
|
6
|
112
|
|
Overall Study
COMPLETED
|
397
|
5
|
97
|
|
Overall Study
NOT COMPLETED
|
32
|
1
|
15
|
Reasons for withdrawal
| Measure |
Tofacitinib 10 mg BID
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Tofacitinib 15 mg BID
Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|---|
|
Overall Study
Other
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
5
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
|
Overall Study
Adverse Event
|
7
|
0
|
2
|
|
Overall Study
Insufficient Clinical Response
|
17
|
0
|
11
|
Baseline Characteristics
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Tofacitinib 15 mg BID
n=6 Participants
Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 44 Years
|
265 participants
n=5 Participants
|
5 participants
n=7 Participants
|
72 participants
n=5 Participants
|
342 participants
n=4 Participants
|
|
Age, Customized
45 to 64 Years
|
139 participants
n=5 Participants
|
1 participants
n=7 Participants
|
35 participants
n=5 Participants
|
175 participants
n=4 Participants
|
|
Age, Customized
Greater Than or Equal to (>=) 65 Years
|
25 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
259 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
317 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Remission in participants 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 Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Percentage of Participants With Remission at Week 8
|
16.6 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Percentage of Participants Achieving Mucosal Healing at Week 8
|
28.4 percentage of participants
|
11.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Clinical response in participants was defined by 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 sub score of at least 1 point or an absolute rectal bleeding sub score 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 centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Response at Week 8
|
55.0 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Remission at Week 8
|
7.0 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Percentage of Participants With Clinical Remission at Week 8
|
16.8 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Symptomatic remission was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Percentage of Participants With Symptomatic Remission at Week 8
|
10.7 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Percentage of Participants With Deep Remission at Week 8
|
5.1 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and each grading from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Partial Mayo Scores
Baseline (n= 428, 112 )
|
6.4 units on a scale
Standard Deviation 1.3
|
6.4 units on a scale
Standard Deviation 1.2
|
|
Partial Mayo Scores
Week 2 (n= 419, 107 )
|
4.4 units on a scale
Standard Deviation 2.2
|
5.4 units on a scale
Standard Deviation 1.7
|
|
Partial Mayo Scores
Week 4 (n= 412, 102 )
|
3.7 units on a scale
Standard Deviation 2.3
|
4.8 units on a scale
Standard Deviation 2.0
|
|
Partial Mayo Scores
Week 8 (n= 401, 98 )
|
3.3 units on a scale
Standard Deviation 2.3
|
4.5 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change in Partial Mayo scores at Weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each graded from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Change at Week 2 (n= 418, 107 )
|
-2.0 units on a scale
Standard Error 0.1
|
-1.0 units on a scale
Standard Error 0.2
|
|
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Change at Week 4 (n= 411, 102 )
|
-2.7 units on a scale
Standard Error 0.1
|
-1.5 units on a scale
Standard Error 0.2
|
|
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Change at Week 8 (n= 400, 98 )
|
-3.0 units on a scale
Standard Error 0.1
|
-1.7 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=429 Participants
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 Participants
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|
|
Change From Baseline in Total Mayo Score at Week 8
Baseline (n=428,112)
|
9.0 units on a scale
Standard Deviation 1.5
|
8.9 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Total Mayo Score at Week 8
Change at Week 8 (n=396,98)
|
-3.7 units on a scale
Standard Deviation 2.8
|
-2.0 units on a scale
Standard Deviation 2.4
|
Adverse Events
Tofacitinib 10 mg BID
Serious events: 18 serious events
Other events: 68 other events
Deaths: 0 deaths
Tofacitinib 15 mg BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo BID
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tofacitinib 10 mg BID
n=429 participants at risk
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Tofacitinib 15 mg BID
n=6 participants at risk
Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 participants at risk
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.89%
1/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
2/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.89%
1/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.9%
8/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
3.6%
4/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.89%
1/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Proctalgia
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Asthenia
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Chills
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Furuncle
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.89%
1/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.89%
1/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Other adverse events
| Measure |
Tofacitinib 10 mg BID
n=429 participants at risk
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Tofacitinib 15 mg BID
n=6 participants at risk
Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
|
Placebo BID
n=112 participants at risk
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
11/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
16.7%
1/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
1.8%
2/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
7/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.4%
6/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
7/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
16.7%
1/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
16.7%
1/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.23%
1/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
16.7%
1/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
16.7%
1/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.6%
7/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
16.7%
1/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
16.7%
1/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
11/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.4%
6/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Headache
|
7.7%
33/429 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/6 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.0%
9/112 • Baseline up to Day 98
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER