FAST 4WARD (Study 011)
In the 24-week FAST 4WARD (eFficAcy and Safety of cerTolizumab pegol - 4 Weekly dosAge in RheumatoiD arthritis, Study O11) phase III study, 220 adult patients with active RA who had previously failed at least one disease-modifying antirheumatic drugs (DMARD) were randomized to receive either CIMZIA 400 mg subcutaneously every four weeks (n=111) or placebo (n=109). Patients were assessed for improvement in signs and symptoms of RA. The primary endpoint of the 011 study was ACR20 responder rate, with secondary measures including ACR50 and ACR70 responder rates.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a progressive autoimmune disease that causes chronic inflammation of the joints. It is estimated that five million people suffer from RA globally, with 0.3 percent to 1 percent of the population in industrialized countries suffering from RA. It is estimated that, approximately 1.3 million people in the United States have RA. Women are three times more likely to be affected than men. Although it can affect people of all ages, the onset of RA usually occurs between the ages of 35-55.
Symptoms of RA include joint stiffness, joint pain, inflammation of the affected areas and an associated reduction in mobility. These symptoms can be intermittent and vary in severity from patient to patient. In more severe cases RA can eventually lead to disability. RA patients are also at a higher risk of developing other conditions, in particular heart disease, stroke, infections, lung problems and osteoporosis.
As there is currently no cure for RA, treatment goals center on disease management and controlling symptoms. Treatment is aimed at controlling disease progression, providing pain relief and reducing swelling, preventing joint damage and deformity and maintaining function of the affected joints to prevent disability.
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