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.
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.