You are here

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

Last updated on November 8, 2019

FOR MORE INFORMATION
Study Location
Internal Medicine Center, LLC
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
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-alpha 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.

NCT01465763
Pfizer
Completed
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Descriptive Information
Brief Title  ICMJE A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe 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 SummaryThis 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 DescriptionNot 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
    Plabebo oral BID
Study Arms  ICMJE
  • Experimental: tofacitinib 10 mg BID
    Intervention: Drug: tofacitinib
  • Placebo Comparator: Placebo
    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 14, 2015)
614
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2011)
545
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion DateMay 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-alpha 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,   Canada,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Latvia,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location CountriesBrazil
 
Administrative Information
NCT Number  ICMJE NCT01465763
Other Study ID Numbers  ICMJE A3921094
2011-004578-27 ( EudraCT Number )
OCTAVEINDUCTION1 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now