Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

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
Home improvement and building products company Masco Corp. said Monday after the markets closed that its second quarter profit jumped 78% from last year, as revenue increased and margins improved amid strong performance of its Plumbing Products, Installation and Other Services and Decorative Architectural Products segments. American Financial Group Inc. (AFG) Monday reported second-quarter net earnings of $106 million or $1.15 per share, compared to $110 million or $1.20 per share last year. Core net operating earnings were $99 million or $1.07 per share, compared to $87 million or $0.96 per share last year. Total... Stocks showed a significant recovery over the course of the trading day on Monday after coming under pressure in early trading. The markets eventually ended the session roughly flat following the mixed performance that was seen last week.
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.