|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01458951 |
|
Date of registration:
|
21/10/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
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
OCTAVE |
|
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. |
|
Date of first enrolment:
|
June 2012 |
|
Target sample size:
|
547 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01458951 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Australia
|
Austria
|
Belgium
|
Brazil
|
Canada
|
Colombia
|
Croatia
|
Czech Republic
|
|
Denmark
|
Estonia
|
France
|
Germany
|
Hungary
|
Israel
|
Korea, Republic of
|
Latvia
|
|
Netherlands
|
New Zealand
|
Poland
|
Romania
|
Russian Federation
|
Serbia
|
Slovakia
|
South Africa
|
|
Spain
|
Taiwan
|
Ukraine
|
United Kingdom
|
United States
| | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion criteria
|
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.
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: tofacitinib
|
|
Primary Outcome(s)
|
|
Percentage of Participants With Remission at Week 8
[Time Frame: Week 8]
|
|
Secondary Outcome(s)
|
|
Percentage of Participants With Clinical Remission at Week 8
[Time Frame: Week 8]
|
|
Partial Mayo Scores
[Time Frame: Baseline, Weeks 2, 4, 8]
|
|
Percentage of Participants Achieving Clinical Response at Week 8
[Time Frame: Week 8]
|
|
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
[Time Frame: Baseline, Weeks 2, 4, 8]
|
|
Change From Baseline in Total Mayo Score at Week 8
[Time Frame: Baseline, Week 8]
|
|
Percentage of Participants Achieving Mucosal Healing at Week 8
[Time Frame: Week 8]
|
|
Percentage of Participants With Deep Remission at Week 8
[Time Frame: Week 8]
|
|
Percentage of Participants With Endoscopic Remission at Week 8
[Time Frame: Week 8]
|
|
Percentage of Participants With Symptomatic Remission at Week 8
[Time Frame: Week 8]
|
|
Secondary ID(s)
|
|
A3921095
|
|
OCTAVEINDUCTION2
|
|
2011-004579-35
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|