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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/NCT01465763




Registration number
NCT01465763
Ethics application status
Date submitted
21/10/2011
Date registered
6/11/2011
Date last updated
7/06/2016

Titles & IDs
Public title
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe 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
2011-004578-27
Secondary ID [2] 0 0
A3921094
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 -


Treatment: Drugs: tofacitinib
10 mg oral BID

Treatment: Drugs: Placebo
Plabebo 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 Scores 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-alpha 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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
614
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Eastern Health Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Wisconsin
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Austria
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Wien
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Belgium
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Leuven
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Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
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Ontario
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Canada
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Quebec
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Colombia
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Atlantico
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Croatia
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Zadar
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Czech Republic
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Hradec Kralove
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Czech Republic
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Praha 4
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Czech Republic
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Praha 7
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Denmark
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Aalborg
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Denmark
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Aarhus C
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Estonia
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Tallinn
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France
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Nantes
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France
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Paris
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France
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Toulouse Cedex 9
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Germany
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Berlin
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Germany
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Halle
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Germany
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Hannover
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Germany
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Lüneburg
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Hungary
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Budapest
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Hungary
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Pecs
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Hungary
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Szeged
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Hungary
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Vac
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Italy
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CZ
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Italy
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Milano
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Italy
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PA
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Italy
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Aviano
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Italy
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Milan
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Japan
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Kochi
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Shiga
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Tokyo
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Hiroshima
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Japan
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Kagoshima
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Latvia
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Riga
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Netherlands
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ZH
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New Zealand
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Auckland
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New Zealand
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Dunedin
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New Zealand
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Tauranga
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Poland
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Kujawsko-pomorskie
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Poland
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Mazowieckie
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Lodz
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Poland
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Wroclaw
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Romania
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Jud Timis
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Russian Federation
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Stavropol Region
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Serbia
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Serbia, Europe
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Slovakia
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Bratislava
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South Africa
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Gauteng
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Madrid
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Ar Krym
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Ukraine
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Kharkov
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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United Kingdom
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Cambridge
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United Kingdom
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London

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01465763
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01465763