This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This will be a two-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study of IL-1 Trap in subjects with relapsing polymyalgia rheumatica. There will be an Open-Label extension phase allowing subjects to receive subcutaneous injections of 320 mg IL-1 Trap weekly for 24 weeks. The study will be conducted in approximately 12 sites in the US. Approximately 40 subjects willbe randomized in a 1:1 ratio to receieve 320 mg of IL-1 Trap or placebo administered subcutaneously. Subjects will receive a total of three doses of study drug on Days 0, 3, and 7 during the two-week Double-Blind phase. There will be no dose escalation within treatment groups. Subjects will be evaluated for efficacy and safety on a regular basis with clinical observations and laboratory measurements including anti-IL trap antibodies, hs-CRP and ESR. Following completion of the primary 2-week double-blind treatment phase, all subjects will be eligible to receive subcutaneous injections of IL-1 Trap 320 mg every week in an Open-Label safety extension phase for an additional 24 weeks.
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