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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
2011-004579-35
Secondary ID [2] 0 0
A3921095
Universal Trial Number (UTN)
Trial acronym
OCTAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Remission at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants Achieving Mucosal Healing at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Response at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Percentage of Participants With Endoscopic Remission at Week 8
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Remission at Week 8
Timepoint [4] 0 0
Week 8
Secondary outcome [5] 0 0
Percentage of Participants With Symptomatic Remission at Week 8
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Percentage of Participants With Deep Remission at Week 8
Timepoint [6] 0 0
Week 8
Secondary outcome [7] 0 0
Partial Mayo Scores
Timepoint [7] 0 0
Baseline, Weeks 2, 4, 8
Secondary outcome [8] 0 0
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Timepoint [8] 0 0
Baseline, Weeks 2, 4, 8
Secondary outcome [9] 0 0
Change From Baseline in Total Mayo Score at Week 8
Timepoint [9] 0 0
Baseline, Week 8

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
547
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Hospital -Concord Repatriation Hospital - Concord
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Liverpool Hospital Eastern Campus - Liverpool
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Kansas
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Louisiana
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Maryland
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Michigan
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Minnesota
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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Pennsylvania
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Tennessee
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Virginia
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Austria
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Innsbruck
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St. Veit an der Glan
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Zagreb
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Tallinn
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jud. Mures
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Nitra
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Presov
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England
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Middlesex
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Norfolk
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United Kingdom
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Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01458951