The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• 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