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.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01465763
First received: October 21, 2011
Last updated: March 17, 2014
Last verified: March 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: January 2015
Estimated Primary Completion Date: December 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465763

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

  Show 185 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: March 17, 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 April 16, 2014