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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/2613

Title: A placebo and active comparator-controlled trial of rofecoxib for the treatment of rheumatoid arthritis
Authors: Geusens, Piet
Truitt, K.
Sfikakis, P.
Zhao, P.L.
DeTora, L.
Shingo, S.
Lau, C.S.
Kalla, A.
Tate, G.
Issue Date: 2002
Abstract: Objective: To evaluate the efficacy and tolerability of rofecoxib 25 mg and 50 mg once daily versus placebo and naproxen 500 mg twice daily in patients with RA. Methods: Eligible patients were randomized (double-blind) to placebo (n = 289), rofecoxib 25 mg (n = 306), 50 mg (n = 286) once daily, or naproxen (n = 142) for 12 weeks. Efficacy assessments included the ACR core set, with prespecified primary endpoints: patient and investigator global assessments of disease activity, tender and swollen joint counts. Investigator-reported adverse experiences, routine laboratory and vital sign measurements were monitored. Results: Rofecoxib 25 mg, 50 mg, and naproxen provided similar treatment effects, significantly different from placebo, consistent with improvement, for all primary endpoints. Effects were evident at the earliest assessment (week 2) and sustained for 12 weeks. All treatments were generally well-tolerated. Conclusions: Rofecoxib 25 mg once daily had similar efficacy to naproxen 500 mg twice daily (a standard dose). No additional benefit was seen with 50 mg rofecoxib.
Notes: Merck & Co Inc, Merck Res Labs, Rahway, NJ 07065 USA. Univ Hosp, Maastricht, Netherlands. Limburgs Univ Centrum, Diepenbeek, Belgium. Liko Gen Hosp, Athens, Greece. Queen Mary Hosp, Hong Kong, Hong Kong, Peoples R China. Old Groote Schuur Hosp, Cape Town, South Africa. Sanatorio Otamendi, Buenos Aires, DF, Argentina.DeTora, L, Merck & Co Inc, Merck Res Labs, 126 E Lincoln Ave,RY 32-645, Rahway, NJ 07065 USA.
URI: http://hdl.handle.net/1942/2613
DOI: 10.1080/030097402320318431
ISI #: 000177729700009
ISSN: 0300-9742
Category: A1
Type: Journal Contribution
Validation: ecoom, 2003
Appears in Collections: Research publications

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