efficacy of remicade in the treatment of active rheumatoid arthritis despite methotrexate (study p03027)

Conditions: Arthritis, Rheumatoid

Summary: this is an open-label program of remicade in the treatment of patients with active rheumatoid arthritis (ra) despite treatment with methotrexate (mtx) to determine the onset of efficacy of infliximab.


Eligibility criteria:
inclusion criteria: * men and women, \>=18 to \<=75 years of age. * diagnosis of ra according to the revised 1987 criteria of the american rheumatism association (arnett et al., 1988). the disease should have been diagnosed at least 6 months prior to screening. * patients have active disease, in the opinion of the physician, despite the concomitant use of dmards. evidence of active disease may include any of the following: 6 or more swollen or tender joints; and 2 of the following * morning stiffness \>45 minutes * c-reactive protein \>2.0 mg/l * esr \>28 mm/h * patients must have been using oral or parenteral mtx for at least 2 months with no break(s) in treatment of more than 2 weeks total during this period. patients must have been on a stable dose of \>=7.5 mg/wk (im, sq, po) for at least 8 weeks prior to screening. * men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, iud, barrier method with spermicide or, surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion. * patients must be on a stable dose of folic acid prophylaxis for at least 4 weeks prior to screening. * patients using oral corticosteroids or nsaids, must have been on a stable dose for at least 4 weeks prior to screening, and must continue during the treatment period. if currently not using corticosteroids or nsaids, the patient must have not received corticosteroids or nasids for at least 4 weeks prior to screening. * patients must be able to adhere to the program visit schedule and other protocol requirements. * patients must be capable of giving informed consent and the consent must have been obtained prior to any screening procedures. exclusion criteria: * pregnant women, nursing mothers or a planned pregnancy within 1.5 years of enrollment * patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care. * patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the remicade therapy, eg, lyme disease, or a rheumatic disease other than ra. * use of dmards other than mtx within 4 weeks prior to screening. * use of intra-articular, im, or iv. corticosteroids (including im acth) within 4 weeks prior to screening. * prior administration any other therapeutic agent targeted at reducing tnf (eg, etanercept, pentoxifylline, thalidomide or anti-cd4+ antibody) within the previous 6 months. * treatment with any investigational drug within the previous 6 months. * a history of known allergies to murine proteins. * serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection need not be considered exclusions at the discretion of the treating physician. * history of opportunistic infections such as herpes zoster within 2 months of screening. evidence of active cmv, active pneumocystis carinii, drug resistant atypical mycobacterium, etc. * documented hiv infection. * current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease. * any currently known malignancy or pre-malignant lesions or any history of malignancy within the past 5 years. * patients with alcoholism, alcoholic liver disease, or other chronic liver disease. * patients with a positive ppd within 3 months and chest x-ray suggestive of active tb or a previous exposure to tb. * patients with chf, even if asymptomatic or not requiring medication must be excluded.