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

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

Outcome

Met primary endpoint

paper Both etoricoxib doses were superior to placebo on both primary efficacy endpoints PMID 27502582 ↗

registry Etoricoxib 60 mg vs Placebo; p = 0.004; Difference in least squares mean -0.29 (95% CI -0.49 to -0.09) NCT01208181 ↗

registry Etoricoxib 90 mg vs Placebo; p = 0.034; Difference in least squares mean -0.27 (95% CI -0.48 to -0.06) NCT01208181 ↗

registry Etoricoxib 60 mg vs Placebo; p <0.001; Difference in least squares mean -7.99 (95% CI -11.85 to -4.13) NCT01208181 ↗

registry Etoricoxib 90 mg vs Placebo; p <0.001; Difference in least squares mean -10.70 (95% CI -14.74 to -6.66) NCT01208181 ↗

Publications

• Results Bickham K, Kivitz AJ, Mehta A, Frontera N, Shah S, Stryszak P, Popmihajlov Z, Peloso PM. Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 8;17:331. doi: 10.1186/s12891-016-1170-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etoricoxib	Small molecule	60 mg	Oral
Subject	Etoricoxib	Small molecule	90 mg	Oral

Indications