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
Shares of Thomas Cook Group Plc. were losing around 11 percent in the morning trading in London after the British tour operator reported Wednesday weak UK margins in its fiscal 2017, despite higher group profit and revenues. Further, the company lifted its final dividend, and said it is well-positioned to achieve a full year operating result in line with market expectations.. Google plans to de-rank articles from Russian state-owned media sites, Russia Today and Sputnik, following allegations about Kremlin meddling in U.S. electoral processes. Eric Schmidt, the executive chairman of Google's parent company Alphabet, said Google would begin to reduce the presence of Russia Today and Sputnik. Federal Communications Commission Chairman Ajit Pai has announced plans to repeal the net neutrality rules implemented under President Barack Obama. Pai, who was appointed by President Donald Trump, said he circulated his draft order to his fellow FCC commissioners Tuesday morning, with the order...
comments powered by Disqus
Follow RTT