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A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis (OCTAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01458951
Recruitment Status : Completed
First Posted : October 25, 2011
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: tofacitinib
Drug: Placebo
Enrollment 547
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Tofacitinib 10 mg BID Tofacitinib 15 mg BID Placebo BID
Hide Arm/Group Description Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period. Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period. Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Period Title: Overall Study
Started 429 6 112
Completed 397 5 97
Not Completed 32 1 15
Reason Not Completed
Other             1             0             0
Protocol Violation             5             1             0
Withdrawal by Subject             2             0             2
Adverse Event             7             0             2
Insufficient Clinical Response             17             0             11
Arm/Group Title Tofacitinib 10 mg BID Tofacitinib 15 mg BID Placebo BID Total
Hide Arm/Group Description Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period. Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period. Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period. Total of all reporting groups
Overall Number of Baseline Participants 429 6 112 547
Hide Baseline Analysis Population Description
The safety analysis set consists of all randomized participants who received at least 1 dose of study medication.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 429 participants 6 participants 112 participants 547 participants
18 to 44 Years 265 5 72 342
45 to 64 Years 139 1 35 175
Greater Than or Equal to (>=) 65 Years 25 0 5 30
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 429 participants 6 participants 112 participants 547 participants
Female
170
  39.6%
3
  50.0%
57
  50.9%
230
  42.0%
Male
259
  60.4%
3
  50.0%
55
  49.1%
317
  58.0%
1.Primary Outcome
Title Percentage of Participants With Remission at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Measure Type: Number
Unit of Measure: percentage of participants
16.6 3.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments P-value based on Cochran-Mantel Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method CMH Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
8.1 to 17.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Mucosal Healing at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Measure Type: Number
Unit of Measure: percentage of participants
28.4 11.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method CMH Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 16.8
Confidence Interval (2-Sided) 95%
9.5 to 24.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Clinical Response at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Measure Type: Number
Unit of Measure: percentage of participants
55.0 28.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method CMH Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 26.4
Confidence Interval (2-Sided) 95%
16.8 to 36.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Endoscopic Remission at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Measure Type: Number
Unit of Measure: percentage of participants
7.0 1.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0425
Comments [Not Specified]
Method CMH Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
1.8 to 8.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Clinical Remission at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Measure Type: Number
Unit of Measure: percentage of participants
16.8 3.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method CMH Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 13.2
Confidence Interval (2-Sided) 95%
8.3 to 18.1
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Symptomatic Remission at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Measure Type: Number
Unit of Measure: percentage of participants
10.7 2.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0090
Comments [Not Specified]
Method CMH Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
3.9 to 12.2
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Deep Remission at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Measure Type: Number
Unit of Measure: percentage of participants
5.1 1.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1408
Comments [Not Specified]
Method CMH Chi-square Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
0.1 to 6.6
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Partial Mayo Scores
Hide Description 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.
Time Frame Baseline, Weeks 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n= 428, 112 ) 6.4  (1.3) 6.4  (1.2)
Week 2 (n= 419, 107 ) 4.4  (2.2) 5.4  (1.7)
Week 4 (n= 412, 102 ) 3.7  (2.3) 4.8  (2.0)
Week 8 (n= 401, 98 ) 3.3  (2.3) 4.5  (2.1)
9.Secondary Outcome
Title Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Hide Description 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.
Time Frame Baseline, Weeks 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Week 2 (n= 418, 107 ) -2.0  (0.1) -1.0  (0.2)
Change at Week 4 (n= 411, 102 ) -2.7  (0.1) -1.5  (0.2)
Change at Week 8 (n= 400, 98 ) -3.0  (0.1) -1.7  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.4 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.6 to -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-1.7 to -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Total Mayo Score at Week 8
Hide Description 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.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tofacitinib 10 mg BID Placebo BID
Hide Arm/Group Description:
Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Overall Number of Participants Analyzed 429 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=428,112) 9.0  (1.5) 8.9  (1.5)
Change at Week 8 (n=396,98) -3.7  (2.8) -2.0  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 10 mg BID, Placebo BID
Comments The change from baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.2 to -1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
Time Frame Baseline up to Day 98
Adverse Event Reporting Description 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.
 
Arm/Group Title Tofacitinib 10 mg BID Tofacitinib 15 mg BID Placebo BID
Hide Arm/Group Description Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period. Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period. Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
All-Cause Mortality
Tofacitinib 10 mg BID Tofacitinib 15 mg BID Placebo BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tofacitinib 10 mg BID Tofacitinib 15 mg BID Placebo BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/429 (4.20%)   0/6 (0.00%)   9/112 (8.04%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/429 (0.00%)  0/6 (0.00%)  1/112 (0.89%) 
Cardiac disorders       
Cardiac failure congestive * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  2/429 (0.47%)  0/6 (0.00%)  0/112 (0.00%) 
Anal fistula * 1  0/429 (0.00%)  0/6 (0.00%)  1/112 (0.89%) 
Colitis ulcerative * 1  8/429 (1.86%)  0/6 (0.00%)  4/112 (3.57%) 
Constipation * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Crohn’s disease * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Intestinal perforation * 1  0/429 (0.00%)  0/6 (0.00%)  1/112 (0.89%) 
Proctalgia * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
General disorders       
Asthenia * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Chills * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Infections and infestations       
Furuncle * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Injury, poisoning and procedural complications       
Femur fracture * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Hip fracture * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/429 (0.00%)  0/6 (0.00%)  1/112 (0.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon adenoma * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
Colon neoplasm * 1  0/429 (0.00%)  0/6 (0.00%)  1/112 (0.89%) 
Vascular disorders       
Hypertension * 1  1/429 (0.23%)  0/6 (0.00%)  0/112 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v.18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tofacitinib 10 mg BID Tofacitinib 15 mg BID Placebo BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   68/429 (15.85%)   4/6 (66.67%)   20/112 (17.86%) 
Blood and lymphatic system disorders       
Anaemia * 1  11/429 (2.56%)  1/6 (16.67%)  2/112 (1.79%) 
Gastrointestinal disorders       
Abdominal pain * 1  7/429 (1.63%)  0/6 (0.00%)  6/112 (5.36%) 
Abdominal pain upper * 1  7/429 (1.63%)  1/6 (16.67%)  0/112 (0.00%) 
Infections and infestations       
Vulvovaginal candidiasis * 1  0/429 (0.00%)  1/6 (16.67%)  0/112 (0.00%) 
Injury, poisoning and procedural complications       
Contusion * 1  1/429 (0.23%)  1/6 (16.67%)  0/112 (0.00%) 
Investigations       
Urine analysis abnormal * 1  0/429 (0.00%)  1/6 (16.67%)  0/112 (0.00%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia * 1  7/429 (1.63%)  1/6 (16.67%)  0/112 (0.00%) 
Hypertriglyceridaemia * 1  0/429 (0.00%)  1/6 (16.67%)  0/112 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  11/429 (2.56%)  0/6 (0.00%)  6/112 (5.36%) 
Nervous system disorders       
Headache * 1  33/429 (7.69%)  0/6 (0.00%)  9/112 (8.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v.18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01458951     History of Changes
Other Study ID Numbers: A3921095
2011-004579-35 ( EudraCT Number )
OCTAVEINDUCTION2 ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2011
First Posted: October 25, 2011
Results First Submitted: April 26, 2016
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016