logo
Share SHARE
FONT-SIZE Plus   Neg

Horizon Pharma Reports Addl Analysis Of Data From Pivotal CAPRA-2 Clinical Trial

Horizon Pharma, Inc. (HZNP) announced an additional analysis of data from the pivotal Circadian Administration of Prednisone in Rheumatoid Arthritis-2 or CAPRA-2 clinical trial demonstrating that patients with active rheumatoid arthritis or RA treated with its recently approved RAYOS 5 mg (prednisone) delayed-release tablets had a significant improvement in reduction of fatigue, as determined by the Functional Assessment of Chronic Illness Therapy - Fatigue or FACIT-F questionnaire.

The efficacy of RAYOS in the treatment of RA was assessed in the CAPRA-2 trial, a double-blind, placebo-controlled, randomized, 12-week trial in patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology or ACR criteria.

Enrolled patients were not currently being treated with corticosteroids but did receive non-biologic disease-modifying antirheumatic drug (DMARD) therapy for at least 6 months prior to receipt of study medication.

Patients were randomized in a 2:1 ratio to treatment with RAYOS 5 mg (n=231) or placebo (n=119) administered at 10 p.m. in addition to their DMARD therapy. Patients ranged in age from 27 to 80 years (median age 57 years) old, were predominantly Caucasian and were predominately (84%) female.

The primary endpoint was the proportion of patients achieving ACR20 response after 12 weeks. A key secondary endpoint was to compare treatment with RAYOS 5 mg and placebo in the change from baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire, a 13-item questionnaire that assesses the effect of fatigue on daily activity and function on a 5-point scale.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
LoopUp Group, a UK-based startup that provides software technology for conference calls and remote meetings, on Wednesday became the first technology company to float shares on the London Stock Exchange since Britain's decision to leave the European Union. LoopUP raised £8.5 million by selling shares... Qatar's sovereign wealth fund has acquired a 9.9 percent stake in the company that owns the iconic Empire State Building, which was once the world's tallest building. Empire State Realty Trust, which owns the 102 storied, 1,454-foot skyscraper, said Tuesday that an affiliate of Qatar Investment Authority or QIA has acquired a 9.9 percent interest in the company through a $622 million investment. Shares of Glencore International Plc. declined around 6 percent in London trading after the Commodities trader reported Wednesday wider pre-tax loss in its first half with weak revenues, amid lower commodity prices. Attributable net loss, however, narrowed from last year.
comments powered by Disqus
Follow RTT