Trial to Evaluate Tumor Necrosis Factor Inhibitor for Rheumatoid Arthritis Patients

The largest clinical trial to date to evaluate the impact of a tumor necrosis factor (TNF) inhibitor in patients with rheumatoid arthritis is about to get underway.

Amgen and Wyeth Pharmaceuticals announced July 9 that 5,000 patients at 400 sites have been enrolled in the second phase of the Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drugs Intervention and Utilization Study (RADIUS).

For at least five years, the study will compare the tolerability, effectiveness and treatment patterns of Enbrel® (etanercept) compared to treatment of a similar number of patients with a variety of disease modifying anti-rheumatic drugs (DMARD). Enbrel will be used in eligible patients either as a monotherapy or in addition to the patient's current DMARD treatment.

"This study is expected to enrich the wealth of information we have about Enbrel and its potential benefits for long-term use in patients with this chronic and progressive disease," said Dr. Jonathan Leff, Amgen's senior director of medical affairs.

Dr. Victoria Kusiak, vice president of global medical affairs and North
American medical director of Wyeth Pharmaceuticals, said the study would give physicians a valuable look at how various therapies are used by community physicians in patients with rheumatoid arthritis.

Enbrel is the only fully human anti-TNF receptor approved for use to
reduce the signs and symptoms and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis, and to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis.

Other sources: Amgen, Wyeth Pharmaceuticals