Arthritis, Rheumatoid Clinical Trial
Official title:
Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
Verified date | March 2017 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | April 1, 2004 |
Est. primary completion date | April 1, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Define the onset of efficacy of infliximab in patients with active RA, using the validated SF-36 questionnaire. | After the first 2 weeks of treatment. |
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