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A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
This is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 1404 |
| Start date | Mon Sep 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Jul 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Arthritis, Rheumatoid
Interventions
- Etoricoxib 60 mg
- Etoricoxib 90 mg
- Placebo to Etoricoxib 60 mg
- Placebo to Etoricoxib 90 mg