A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-007859-14

A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE

Femme et Homme

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Extrait

• To compare the efficacy of 3 dose levels of ARRY-438162 (10 mg BID, 40 mg QD, and 20 mg BID) versus placebo, administered over 12 weeks for the treatment of the signs and symptoms of patients with RA. • To determine the American College of Rheumatology 20% (ACR20) best response rate at Week 12 of patients treated with any well-tolerated dose. • To evaluate the safety of ARRY-438162 in patients with active RA on stable doses of methotrexate (≥10 mg ≤ 25 mg) for ≥ 6 weeks.


Critère d'inclusion

  • Active Rheumatoid Arthritis incompletely responsive to methotrexate