Clinical trial
A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid…
NCT00264537 · Centocor, Inc., Industry · Completed
Key facts
| NCT number | NCT00264537 |
|---|---|
| Title | A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive |
| Official title | A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis |
| Lead sponsor | Centocor, Inc., Industry |
| Collaborators | Schering-Plough Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Rheumatoid Arthritis |
| Intervention type | Biological, Drug |
| Interventions | Placebo injections, Placebo capsules, Methotrexate capsules, Golimumab 50 mg injections, Golimumab 100 mg injections |
| Enrollment | 637 |
| Start date | Dec 1, 2005 |
| Primary completion | Apr 1, 2008 |
| Completion | Jun 1, 2012 |
| First posted | Dec 13, 2005 |
| Last update posted | Sep 5, 2014 |
| Countries | Argentina, Australia, Austria, Belgium, Canada, Chile, Hungary, India, Malaysia, New Zealand, Philippines, Poland and 9 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: