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Articles tagged with "clinical trials"

Guselkumab Studied to Treat RA, Plaque Psoriasis

Michele B. Kaufman, PharmD, BCGP  |  September 15, 2015

Guselkumab Studied to Treat RA & Plaque Psoriasis Guselkumab (GUS) is a subcutaneously administered monoclonal antibody that targets interleukin (IL) 23.1 It is being investigated in a Phase 2 study to treat rheumatoid arthritis (RA) and moderate to severe plaque psoriasis (PsA). On June 11, 2015, at the 2015 meeting of the European League Against…

Biosimilar Drugs for RA Studied in Multiple Trials

Michele B. Kaufman, PharmD, BCGP  |  August 17, 2015

Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…

New Analysis Underscores Improving Pharma R&D Productivity

Ben Hirschler  |  August 4, 2015

LONDON (Reuters)—Drug industry productivity is continuing to improve, with a bumper haul of new products being launched and companies proving more successful in the final stages of clinical testing, according to a new analysis. Data from Thomson Reuters published on Tuesday showed the number of innovative medicines, or new molecular entities, launched globally in 2014…

Adverse Event Risk Data Drive Evaluation of Psoriasis Treatments

Michele B. Kaufman, PharmD, CGP, RPh  |  July 14, 2015

PSOLAR, the Psoriasis Longitudinal Assessment and Registry, is a multicenter, longitudinal, intercontinental, disease-based registry used to identify adverse events from commonly used psoriasis drugs.1 An evaluation of the risk of serious infection from systemic psoriasis treatments was recently published using data from PSOLAR. Ninety-three institutional review boards or ethics committees reported into the registry from…

Second Indian Firm Under Fire for Shoddy Clinical Drug Trials

Ben Hirschler & Zeba Siddiqui  |  July 8, 2015

LONDON/MUMBAI (Reuters)—Another Indian clinical research organization, Quest Life Sciences of Chennai, is in trouble over defective trials work, according to a warning issued by the World Health Organization. The action by the United Nations health agency follows an earlier scandal over drug testing at GVK Biosciences, which resulted in approvals for hundreds of generic drugs…

Nurses May Be Key to Long-Term Clinical Trial Success

Lara C. Pullen, PhD  |  July 6, 2015

After completing a 10-year clinical trial examining treatment strategies for rheumatoid arthritis, Dutch researchers used a questionnaire to determine the study conditions and individual motivators that kept 60% of patients participating long term…

Biosimilars for RA Studied in Multiple Trials

Michele B. Kaufman, PharmD, BCGP  |  June 17, 2015

Biosimilars for etanercept and sarilumab are being examined in multiple Phase 3 trials for their effects in RA and psoriasis patients.

Registered Nurses Can Help Guide Rheumatology Patients Through Clinical Trials

Tara L. Barker, RN, BSN, MSN  |  March 1, 2014

How RN research coordinators can prevent deviations, interruptions in rheumatology clinical trials and enhance patient care

Ethics Forum: The Ethical Challenges of Recruiting Patients for Clinical Trials

Carol M. Greco, PhD, and Donah Zack Crawford, MA  |  February 1, 2014

A successful recruiter raises concerns about balancing friendliness and enthusiasm with legal and ethical constraints when screening human subjects for research

2013 ACR/ARHP Annual Meeting: Rheumatology Year in Review

Mary Beth Nierengarten  |  December 1, 2013

Progress in treatments for pediatric rheumatic diseases, collaborative clinical trials, and personalized therapeutic approaches highlight the past year in rheumatology

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