Status:
COMPLETED
The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol
Lead Sponsor:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of the study was to evaluate the ability of a maintenance dosage regimen of infliximab to achieve and sustain at least 40% improvement from baseline in the total joint count in patients wi...
Detailed Description
Rheumatoid arthritis (RA) is a chronic autoimmune disorder of unknown etiology that occurs in approximately one percent of the population. Current therapy for RA comprises non-steroidal anti-inflammat...
Eligibility Criteria
Inclusion
- Previous diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al., 1988)
- patients must have a minimum of 8 tender and 4 swollen joints with disease diagnosed at least 3 months prior to screening
- patients must have been using oral or parenteral MTX for at least the previous 3 months, and at a stable dose of 7.5 to 25 mg per week for at least the previous 1 month
- women of childbearing potential must test negative for pregnancy and be using adequate birth control measures
- patients must have a documented purified protein derivative (PPD) skin test performed at prescreening.
Exclusion
- Patients who have received any prior treatment with infliximab or with any other therapeutic agent targeted at reducing tumor necrosis factor (TNF) (e.g., etanercept, pentoxifylline or thalidomide) within the previous 3 months
- patients who are incapacitated
- history of infected joint prosthesis within the previous 5 years
- patients with a concomitant diagnosis of congestive heart failure (CHF), history of or known malignancy within the previous 5 years, cases of active or latent tuberculosis (TB), acute or chronic serious infections within the past 3 months
- known substance abuse (drug or alcohol) within the previous 3 years
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00246064
Start Date
December 1 2001
End Date
November 1 2003
Last Update
May 19 2011
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