Clinical trial
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With…
NCT00488631 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT00488631 |
|---|---|
| Title | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis |
| Official title | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Collaborators | Merck Sharp & Dohme LLC Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative |
| Intervention type | Biological |
| Interventions | Placebo, Golimumab 50 mg, Golimumab 100 mg, Golimumab 200 mg |
| Enrollment | 1,228 |
| Start date | Sep 1, 2007 |
| Primary completion | Oct 1, 2011 |
| Completion | Feb 1, 2015 |
| First posted | Jun 20, 2007 |
| Last update posted | Apr 26, 2016 |
| Countries | Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, India, Israel and 14 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: