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Safety Study for Remicade



Safety Study for Remicade

For Condition: Rheumatoid Arthritis
Status: No longer recruiting
Sponsor(s): Centocor ,
Synopsis: To assess the relative risk for serious infection in infliximab-treated patients within the first 22 weeks after initiation of therapy in a population of patients with rheumatoid arthritis (RA) reflective of the demographics (severity of RA, background disease-modifying anti-rheumatic drugs, concomitant diseases) seen in clinical practice.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 18 years or older - diagnosis of RA at least 3 months before screening using revised 2000 criteria of the American Rheumatism Association - active RA (at least 6 swollen and 6 tender joints due to RA) - concomitant MTX treatment of 25 mg/kg for > 3 months stable dose for at least 4 weeks prior to week 0 stable dose of other concomitant medications - chest X-ray and tuberculosis screening Exclusion Criteria - pregnancy, nursing or planning pregnancy within 18 months of enrollment - have a rheumatic disease other than RA or any current systemic inflammatory conditions with signs and symptoms that might confound the evaluations from the Infliximab therapy - previous treatment with any approved or investigational biologic agent (except vaccines for immunizations) - treated with any investigational drug within the previous 3 months or within 5 half-lives, whichever is greater - previous or current use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents - currently on > 5 mg cyclosporine treatment - history of any clinically significant adverse reaction to murine or chimeric proteins - have had a serious infection in the previous 2 months - have active TB - have history of active TB without having completed a course of anti-tubercular therapy at least 2 years prior to the baseline visit - have positive skin-test and refuses prophylaxis for tuberculosis - have a history of chronic or recurrent infectious disease - have a serious illness that is rapidly worsening or might deteriorate over the course of the study - have a history of or signs suggestive of lymphoproliferative disease or signs - have known malignancy or history of malignancy within the previous 5 years - have had substance abuse (drug or alcohol) within the previous 3 years - unable or unwilling to undergo multiple venipunctures - have current side effects related to MTX - have a concomitant diagnosis of CHF, including medically controlled asymptomatic patients
Total Enrollment: 

Location and Contact Information:

University of Arizona-Arizona Arthritis Center
Tucson,  Arizona,  85724
United States
 


Additional Information:
Study ID Numbers:  CO168T41; 
Study Start Date: September 2001
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036387

Other Rheumatoid Arthritis Studies:
1. Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis

2. Coping Skills Training for Early Rheumatoid Arthritis

3. Antifolate Effectiveness in Arthritis

4. Specimen Collection for Individuals with Lung Disease Associated with Rheumatoid Arthritis

5. Safety Study for Remicade

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