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
In order to make Facebook more user-friendly, the social media giant introduced a few attractive new features. Recommendation tool, call-to-action buttons, and new section pages are expected to attract more users in a world where there are more mobiles than human beings. Starbucks Coffee Co. said Thursday that it plans to open a Reserve Roastery in Japan in 2018. This will be the coffee giant's fourth Roastery location globally. The new location will be located in Tokyo's upscale Nakameguro district, known for its exclusive boutiques and art galleries. Verizon Communications Inc. (VZ) reported third-quarter adjusted earnings per share of $1.01 compared to $1.04, prior year. On average, 22 analysts polled by Thomson Reuters expected the company to report profit per share of $0.99 for the quarter. Analysts' estimates typically exclude special items....
comments powered by Disqus
Follow RTT