Posted on March 1, 2004 at 12:53 p.m.
BIRMINGHAM, AL — The University of Alabama at Birmingham (UAB) is leading a national study to determine the best course of treatment for patients diagnosed with early aggressive rheumatoid arthritis. Amgen is funding the five-year, $19.5 million study, and Amgen, Barr Laboratories Inc. and Pfizer Inc. are providing the drugs for the trial.
“Recent studies strongly support intensive treatment early on to prevent or slow disease progression,” said Dr. Larry Moreland, professor of medicine with the Division of Clinical Immunology/Rheumatology at UAB and lead investigator. “This study will examine whether a combination therapy of two or more anti-rheumatic drugs may yield better long-term results than the traditional step-up therapy from one to a combination of drugs.”
Rheumatoid arthritis is a chronic illness characterized by inflammation of the joints, causing pain and stiffness. One of the most the common forms of arthritis, it affects approximately 2.1 million Americans, mostly women.
“The ultimate goal in treating rheumatoid arthritis is to eliminate the patient’s symptoms and to maintain the structural integrity of the joints,” Moreland said. “This goal can only be achieved at the onset of the disease, before any irreversible joint or cartilage damage has occurred.”
Treatment of rheumatoid arthritis has changed markedly in recent years, in part due to the introduction of new disease modifying anti-rheumatic drugs, or DMARDs, such as leflunomide, etanercept, infliximab and others. “Among traditional DMARDs, methotrexate has emerged as the preferred first-line treatment,” Moreland said. “Traditionally, rheumatologists have taken a step-up approach, treating initially with methotrexate alone, then supplementing with other DMARDs as patients begin to show signs of disease progression.”
Recent data suggests early treatment with a combination of DMARDs may reduce the number of patients who advance to severe disability. “However, this would mean prescribing combination therapies early even for patients who may have responded well to methrotrexate alone,” Moreland said. “So we need to carefully evaluate the risks and benefits of early combination therapies.”
The national multicenter study, coordinated by UAB, will recruit 750 men and women diagnosed with early aggressive rheumatoid arthritis within the last three years. Following an initial screening, patients enrolled in the study will be randomly assigned to a treatment group to receive one of four step-up or combination therapies being evaluated. Patients will visit the clinic every 12 weeks for 102 weeks. Laboratory visits will be scheduled in between clinic visits.
For a list of participating centers or for more information about enrolling in the study, contact Dr. Larry Moreland at lwm@uab.edu or (205) 934-7727.