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

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.