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

NCT01458951

Last updated date
Study Location
Desert Sun Clinical Research, LLC
Tucson, Arizona, 85710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: tofacitinib
    10 mg oral BID
    Other Name: CP-690,550
  • Drug: Placebo
    Placebo oral BID
Study Arms  ICMJE
  • Experimental: tofacitinib 10 mg BID
    Intervention: Drug: tofacitinib
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2015)
547
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
545
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01458951
Other Study ID Numbers  ICMJE A3921095
2011-004579-35 ( EudraCT Number )
OCTAVEINDUCTION2 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP