RA Biosimilar Recruitment

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Diagram of Human Organs

Inflammatory Bowel Disease Clinical Studies – Where Do We Go From Here?

Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large …

The Advantage of Applying a Multifaceted Approach in Cystic Fibrosis Clinical Research

As a complex, inherited disease, cystic fibrosis impacts the respiratory, gastrointestinal and reproductive systems. Many clinical trials are examining therapies that target this rare disease from different therapeutic angles, such as restoring function to a faulty protein, reducing inflammation, clearing mucus buildup, addressing gastrointestinal manifestations or fighting cystic fibrosis-related infections.

The Promise of Vaccines for Fighting C. difficile

Over the last decade, Clostridium difficile (C. difficile) infection has rapidly become more prevalent. C. difficile, often abbreviated as C. diff, usually spreads through hospitals and other healthcare facilities, and the elderly are particularly vulnerable. Our society’s overuse of antibiotics has been eliminating normal microbes, allowing C. difficile to take …

New Mechanisms of Action for Disease Modification in RA

Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint stiffness and loss of function, ultimately leading to disability if untreated. RA also produces significant systemic affects such as fatigue and depression that may appreciably impact quality of life for …

RA Map

An Analytical Approach to Enhance Recruitment of Rheumatoid Arthritis Patients

No single blood test or physical finding alone can confirm the diagnosis of rheumatoid arthritis (RA). However, two tests that detect markers of inflammation are often ordered when RA is suspected: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Other common tests include rheumatoid factor and anti-CCP antibodies. While the …