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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

p=0.058 ---------- ----- ----- ------- Erosion Score +0.94 +0.78 p=0.62 ------------- ----- ----- ------ * RAMRIS is a rheumatoid arthritis scoring system utilizing magnetic resonance imaging to evaluate abnormalities (synovitis, bone edema and bone erosion) in the hands and wrists. The system was developed by OMERACT, (Outcome Measurements in Rheumatology) in 2002, and has become a global standard measurement of inflammation and destruction in those joints. For these scores a lower value indicates a better clinical condition. ** Synovitis: inflammation of the synovial membrane lining joints Osteitis: inflammation of the bone

Safety Results

Similar to TASKi2, the most common clinically meaningful drug-related adverse events noted in TASKi3 were diarrhea and hypertension. Dose reduction options were pre-specified in the trial protocol and, in cases where doses were reduced, patients generally completed the clinical trial with minimal safety issues. The most common adverse events in the trial overall were related to infections, though these were generally evenly distributed among the placebo and active dose group.

The mean increase in blood pressure from baseline at 3 months, using a last observation carry forward methodology, was 3.2-3.6 mmHg for the 100 mg bid dose group. In TASKi3, approximately 17% of patients in the 100 mg bid dose group had blood pressure medication adjusted or in some cases initiated during the course of the clinical trial, compared to 8% of the placebo patients. For those patients who had their dose of blood pressure medications adjusted or initiated, their blood pressure was successfully reduced and their blood pressure was generally well controlled throughout the trial. The blood pressure medications were standard doses of commo
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SOURCE Rigel Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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