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R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent
Date:7/23/2009

Placebo 100 mg bid ------- ---------- N 73 146 -- --- --- Diarrhea 5 7% 17 12% -------- --- --- --- --- Hypertension 3 4% 19 13% ------------ --- --- --- --- Infections 15 21% 34 23% ---------- --- --- --- --- Mean Blood Pressure (Systolic/Diastolic in mmHg) Baseline 128/78 125/77 -------- ------ ------ Month 3 126/77 129/81 ------- ------ ------ Change from Baseline to Month 3 (LOCF) -2.1/-0.5 +3.6/+3.2 -------------------- ---------- -------- N % N % --- --- --- --- # and % Had BP Meds Adjusted/Initiated 6 8% 25 17% ------------------- --- --- --- ---

Trial Design

TASKi3 was a 3 month, multi-center, randomized, double blind, placebo controlled, parallel dose clinical trial involving 219 RA patients in the U.S. who had failed to respond to at least one biologic treatment (such as TNF inhibitors). The patients were randomly assigned to two cohorts and thus received R788 orally in a 100 mg bid (twice daily) dose or placebo for a period of up to 3 months. Patients were assigned on a 2:1 basis to R788 or placebo. Throughout the clinical trial period, all of the patients continued to receive their stable dose of methotrexate.

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SOURCE Rigel Pharmaceuticals, Inc.
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