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Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial
Date:7/9/2009

BP if had Adjustment or Initiation of BP Medication (mmHg) # Had BP Meds Adjusted/Initiated 11 (7%) 27 (18%) 35 (23%) BP Measurement Pre-Adjustment/Initiation 139 149 153 At Month 6 136 128 138 Mean Change -4 -20 -16

Study Design

TASKi2 was a 6 month, multi-center, randomized, double blind, placebo controlled, parallel dose clinical trial involving 457 RA patients in the U.S., Latin America and Europe who had failed to respond to methotrexate alone. The patients were randomly assigned to two cohorts and thus received R788 orally in either 100 mg bid (twice daily) or 150 mg qd (once daily) doses or placebo for a period of 6 months. Within in each cohort, patients were assigned on a 2:1 basis to R788 or placebo. All of the patients continued to receive their same stable dose of methotrexate throughout the clinical trial period.

Efficacy assessments for each participant were based on the American College of Rheumatology criteria, which denotes at least a 20% (ACR 20) improvement, at least a 50% (ACR 50) improvement, or at least a 70% (ACR 70) improvement, from the baseline assessment at the end of the 6 month treatment period. The ACR measurement factors include reported physician and patient global assessment of disease activity, patient reported pain score, and any change in C-reactive protein (CRP) in the patients' blood. The primary efficacy endpoint for the study was the percent of patients assigned to the R788 100 mg bid dose who were ACR 20 responders at the end of 6 months. Secondary efficacy endpoints included a comparison of response rates for the R788 100 mg bid and R788 150 mg qd doses at the ACR 20, ACR 50 and ACR 70 scores, as well as Disease Activity Scores (DAS) over the period of 6 months.


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SOURCE Rigel Pharmaceuticals, Inc.
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