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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01458951
Registration number
NCT01458951
Ethics application status
Date submitted
21/10/2011
Date registered
25/10/2011
Date last updated
1/06/2016
Titles & IDs
Public title
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
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Scientific title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
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Secondary ID [1]
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2011-004579-35
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Secondary ID [2]
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A3921095
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Universal Trial Number (UTN)
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Trial acronym
OCTAVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tofacitinib
Treatment: Drugs - Placebo
Experimental: tofacitinib 10 mg BID -
Placebo Comparator: Placebo BID -
Treatment: Drugs: tofacitinib
10 mg oral BID
Treatment: Drugs: Placebo
Placebo oral BID
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Remission at Week 8
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Secondary outcome [1]
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Percentage of Participants Achieving Mucosal Healing at Week 8
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Secondary outcome [2]
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Percentage of Participants Achieving Clinical Response at Week 8
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Assessment method [2]
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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.
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Timepoint [2]
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Week 8
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Secondary outcome [3]
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Percentage of Participants With Endoscopic Remission at Week 8
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Assessment method [3]
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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.
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Timepoint [3]
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Week 8
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Secondary outcome [4]
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Percentage of Participants With Clinical Remission at Week 8
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Assessment method [4]
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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.
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Timepoint [4]
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Week 8
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Secondary outcome [5]
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Percentage of Participants With Symptomatic Remission at Week 8
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Assessment method [5]
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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.
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Timepoint [5]
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Week 8
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Secondary outcome [6]
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Percentage of Participants With Deep Remission at Week 8
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Assessment method [6]
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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.
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Timepoint [6]
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Week 8
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Secondary outcome [7]
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Partial Mayo Scores
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Weeks 2, 4, 8
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Secondary outcome [8]
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Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Weeks 2, 4, 8
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Secondary outcome [9]
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Change From Baseline in Total Mayo Score at Week 8
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 8
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Eligibility
Key inclusion criteria
- Subject must be at least 18 years of age.
- Males and females with a documented diagnosis of UC at least 4 months prior to entry
into the study.
- Subjects with moderately to severely active UC based on Mayo score criteria.
- Subjects must have failed or be intolerant of at least one of the following treatments
for UC:
- Corticosteroids (oral or intravenous).
- Azathioprine or 6 mercaptopurine (6 MP).
- Anti TNF therapy.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease.
- Subjects with disease limited to distal 15 cm.
- Subjects without previous treatment for UC (ie, treatment naïve).
- Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2015
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Sample size
Target
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Accrual to date
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Final
547
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Concord Hospital -Concord Repatriation Hospital - Concord
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Concord Repatriation General Hospital - Concord
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Liverpool Hospital Eastern Campus - Liverpool
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Recruitment hospital [5]
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Monash Medical Centre - Clayton
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2605 - Garran
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in
patients with moderate to severe ulcerative colitis who have failed or be intolerant to one
of following treatments for ulcerative colitis: oral steroids,
azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01458951
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01458951
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