An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.

Key facts

Study ID

NCT00488631

Run by

Janssen Research & Development, LLC

People needed

1228

Starts

2007-09-01

Expected to finish

2015-02-01

Last updated by the study team

2016-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
• Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)

You may not qualify if…

• Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
• Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
• Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
• Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C
• Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Merced, California, United States
• Study site — Orange, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Bristol, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Boca Raton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Naples, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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