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
Toyota is working on developing an electric car with a fast charging battery, the Chunichi Shimbun reported on Tuesday. Travelers leaving Comic-Con International in San Diego last weekend were in for a rude shock after United Airlines said that comic books were banned in their checked luggage. United Airlines claimed it was a Transportation Security Administration or TSA-mandated rule for all airlines operating out of San Diego over this weekend. A Singapore-based startup wants to make cryptocurrencies like Bitcoin go mainstream and be available for everyday transactions. TenX has built an app that serves as a digital wallet connected to the Visa card. The debit card will instantly convert multiple digital currencies into fiat money such as the dollars, yen and euros.
comments powered by Disqus
Follow RTT