Clinical trial
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative…
NCT00488774 · Janssen Research & Development, LLC, Industry · Terminated
Key facts
| NCT number | NCT00488774 |
|---|---|
| Title | An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis |
| Official title | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Collaborators | Merck Sharp & Dohme LLC Industry |
| Status | Terminated |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative |
| Intervention type | Drug, Other |
| Interventions | Placebo, Golimumab 1 mg per kg, Golimumab 2 mg per kg, Golimumab 4 mg per kg |
| Enrollment | 291 |
| Start date | Aug 1, 2007 |
| Primary completion | May 1, 2009 |
| Completion | May 1, 2009 |
| First posted | Jun 20, 2007 |
| Last update posted | Jun 14, 2013 |
| Countries | Australia, Austria, Belgium, Bulgaria, Canada, France, Germany, Hungary, India, Israel, Latvia, Lithuania and 10 more |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: