期刊
JOURNAL OF RHEUMATOLOGY
卷 43, 期 9, 页码 1637-1642出版社
J RHEUMATOL PUBL CO
DOI: 10.3899/jrheum.160164
关键词
HISTAMINE H-4 RECEPTOR ANTAGONIST; RHEUMATOID ARTHRITIS; METHOTREXATE; CLINICAL TRIAL
类别
Objective. To assess toreforant (selective histamine H-4 receptor antagonist) in active rheumatoid arthritis (RA). Methods. In a phase IIa, double-blind, placebo-controlled test, 86 patients were randomized (2: 1) to once-daily toreforant 100 mg or placebo for 12 weeks. In phase IIb, double-blind, placebo-controlled, dose-range-finding evaluations, 272 patients were randomized (1: 1: 1: 1) to once-daily placebo or toreforant 3/10/30 mg. Primary efficacy endpoints for both studies were Week 12 changes in 28-joint Disease Activity Score-C-reactive protein (DAS28-CRP). Results. Phase IIa testing was terminated prematurely (patient fatality; secondary hemophagocytic lymphohistiocytosis). Posthoc analyses indicated toreforant 100 mg/day reduced RA signs/symptoms through Week 12. Phase IIb testing, however, showed no significant Week 12 improvement in DAS28-CRP with toreforant. Conclusion. Toreforant was not effective in phase IIb testing.
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