drugset / Trial / NCT01208181

A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)

NCT01208181

Phase 3 Completed 1404 enrolled Organon and Co
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2010-09-27
Primary completion
2014-06-09
Completion
2014-07-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Etoricoxib Small molecule 60 mg Oral
Subject Etoricoxib Small molecule 90 mg Oral

Indications