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A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclona...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001550-27

A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate

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Extrait

To assess the efficacy of three dose regimens of ACZ885 ( (1) 600 mg i.v. loading dose plus 300 mg s.c. q2wk, (2) 300 mg s.c. q2wk, (3) 150 mg s.c. q4wk) compared to placebo as add-on treatment in patients with active RA despite stable treatment of MTX at the maximum tolerated dose (<_ 25 mg/week) for at least 12 weeks, by assessing the response to treatment (ACR50 criteria) after 12 weeks.

Critère d'inclusion

  • active rheumatoid arthritis

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