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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Placebo
Drug: tofacitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01458951
2011-004579-35 (EudraCT Number)
OCTAVEINDUCTION2 (Other Identifier)
A3921095

Details and patient eligibility

About

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.

Enrollment

547 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

547 participants in 2 patient groups, including a placebo group

tofacitinib 10 mg BID
Experimental group
Treatment:
Drug: tofacitinib
Placebo BID
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

182

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Data sourced from clinicaltrials.gov

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