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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01465763
First received: October 21, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: tofacitinib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects in remission at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects achieving mucosal healing at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving clinical response at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    based on the Mayo score

  • The proportion of subjects in clinical remission at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    based on the Mayo score

  • The proportion of subjects in symptomatic remission at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    based on the Mayo score

  • The proportion of subjects achieving deep remission at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    based on the Mayo score

  • Partial Mayo scores and change from baseline over time. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline at Week 8 in total Mayo score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 545
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tofacitinib 10 mg BID Drug: tofacitinib
10 mg oral BID
Other Name: CP-690,550
Placebo Comparator: Placebo Drug: Placebo
Plabebo oral BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465763

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 190 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01465763     History of Changes
Other Study ID Numbers: A3921094
Study First Received: October 21, 2011
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
tofacitinib
CP-690
550
Moderate to severe ulcerative colitis
phase 3 clinical trial
Mayo score

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014