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A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination W...

Update Il y a 5 ans
Reference: EUCTR2006-005466-39

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy

Woman and Man

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Extract

To evaluate the efficacy of 5 dose regimens of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to conventional DMARD therapy. The primary efficacy outcome measure is the proportion of subjects with ACR50 at Week 14. To achieve ACR50 response, a 50% improvement compared to baseline is required for both swollen and tender joint counts, as well as 3 out of 5 additional parameters: subject’s global assessment of disease activity, Investigator’s global assessment of disease activity, subject’s assessment of pain, HAQ-DI, and hsCRP or ESR.

Inclusion criteria

  • Rheumatoid arthritis (RA)

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