Overview

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

Status:
Terminated
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Antibodies, Monoclonal
Golimumab
Criteria
Inclusion Criteria:

- Participants diagnosed with moderately to severely active ulcerative colitis (UC)
defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an
endoscopic (examination of an internal part of the body with a lighted tube; looking
at a part of the body with a lighted tube) subscore of greater than or equal to 2

- Participants must have biopsy results (collected at the screening endoscopy (procedure
or obtained within the last year) consistent with the diagnosis of UC

- Participants either currently receiving treatment with, or have a history of failure
to respond to, or tolerate, at least 1 of the following therapies: oral
5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and
azathioprine (AZA)

- Participants with current dependency or with a history of corticosteroid dependency
(i.e. an inability to successfully taper corticosteroids without a return of the
symptoms of UC) - Not have a diagnosis of active TB

Exclusion Criteria:

- Participants with previous exposure to biologic anti-tumor necrosis factor (TNF)
agents

- Participants with severe extensive UC that is likely to require a colectomy (surgery
to remove part or all of the colon) within 12 weeks of study entry

- Participants having UC limited to the rectum only or to less than 20 centimeter (cm)
of the colon

- Presence of a stoma (an artificial permanent opening especially in the abdominal wall
made in surgical procedures) or presence of a fistula

- Participants with a history of extensive colonic resection