At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Etoricoxib 60 mg, Etoricoxib 90 mg, and 2 other interventions for Arthritis, Rheumatoid. Completed, enrolled 1,404 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
One tablet orally once daily for 6 weeks.
One tablet orally once daily for 6 weeks.
One tablet orally once daily for 6 weeks.
One tablet orally once daily for 6 weeks