NCT01208181

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,404 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Etoricoxib 60 mg	One tablet orally once daily for 6 weeks.
DRUG	Etoricoxib 90 mg	One tablet orally once daily for 6 weeks.
DRUG	Placebo to Etoricoxib 60 mg	One tablet orally once daily for 6 weeks.
DRUG	Placebo to Etoricoxib 90 mg	One tablet orally once daily for 6 weeks

Timeline

• Start date: 2010-09-27
• Primary completion: 2014-06-09
• Completion: 2014-07-29
• First posted: 2010-09-23
• Last updated: 2024-06-18
• Results posted: 2015-05-21