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Biotech / Medical : Cambridge Antibody Technology Group -- Ignore unavailable to you. Want to Upgrade?


To: nigel bates who wrote (440)1/12/2004 10:53:05 AM
From: keokalani'nui  Read Replies (1) | Respond to of 625
 
Re: LymphostatB trial:

Human Genome Sciences announced on Thursday, January 8, 2004 that it has begun enrolling and dosing patients in a double-blind, placebo-controlled, multi-center Phase 2 clinical trial that will evaluate the safety, optimal dosing, and efficacy of LymphoStat-B in patients with rheumatoid arthritis.(1) Approximately 230 patients with active rheumatoid arthritis who have failed prior therapy will be enrolled in the trial and randomized to receive intravenously 1 mg/kg, 4 mg/kg, or 10 mg/kg of LymphoStat-B or placebo every four weeks over a 24-week treatment period. Efficacy will be evaluated in the trial according to the American College of Rheumatology (ACR) criteria for defining clinical improvement in rheumatoid arthritis patients. The primary efficacy endpoint for the Phase 2 trial in rheumatoid arthritis will be the rate of response at week 24 (i.e., the percentage of patients who achieve at least 20% improvement on the ACR-specified measures of disease activity).