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A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid A...

Update Il y a 4 ans
Reference: EUCTR2009-012705-19

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy

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Extract

The primary objectives of this study are: • To evaluate the safety and tolerability of three dose levels of LX3305 over 12 weeks in subjects with active RA who are also receiving stable doses of MTX; • To evaluate the efficacy of three dose levels of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA who are also receiving stable doses of MTX.

Inclusion criteria

  • Rheumatoid arthritis (RA)

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