Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

11/11/2012 9:11 AM ET

Horizon Pharma, Inc. (HZNP: Quote) 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.

Register
To receive FREE breaking news email alerts for Horizon Pharma Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Russian Foreign Minister Sergei Lavrov warned Wednesday that Moscow would retaliate strongly if its "interests" in Ukraine are attacked. He also criticized the Ukrainian administration for relaunching its so-called anti-terrorist operation in the east of the country a day earlier. Lavrov's remarks came in an interview with Russia Today, which published excerpts of the English-language interview to While selling pressure has remained relatively subdued, stocks continue to see modest weakness in mid-day trading on Wednesday. The losses on the day come on the heels of the upward trend seen over the past several sessions. The major averages have moved roughly sideways in recent trading, lingering in the red. While a majority of Kentucky voters approve of the way Rand Paul is handling his job as Senator, the results of New York Times/Kaiser Family Foundation poll showed that voters from the Bluegrass State have a more mixed view on Paul's potential run for president in 2016.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.