Overview
The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol
Status:
Completed
Completed
Trial end date:
2003-11-01
2003-11-01
Target enrollment:
0
0
Participant gender:
All
All
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 with active Rheumatoid Arthritis (RA) during methotrexate tapering.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Centocor Ortho Biotech Services, L.L.C.Treatments:
Infliximab
Methotrexate
Criteria
Inclusion Criteria:- 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 Criteria:
- 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