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

Editors Pick
Major League Baseball is talking expansion for the first time in a few decades. Owners stand to make a pretty penny from expansion fees and subsequent television rights. The possibility of a more balanced schedule is also enticing. Strong expansion candidates in the U.S. and Canada are ready... The New York Times is teaming up with Google again to give away Google Cardboard, the virtual reality headsets, but this time only to its "most loyal" digital subscribers. The company said that the digital-only subscribers selected for this distribution were chosen based on the duration of their subscriptions. Oil company Exxon Mobil Corp. on Friday reported a 63 percent fall in profit for the first quarter from last year, while Chevron Corp. reported a loss for the quarter, both on lower revenues. The results were impacted by the fall in crude oil prices and weaker refining margins. However, Exxon Mobil's earnings beat analysts' estimates, while Chevron's loss was wider than their expectations.
comments powered by Disqus
Follow RTT