Arthritis, Rheumatoid Clinical Trial
Official title:
The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol. Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With Infliximab
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.
Status | Completed |
Enrollment | 210 |
Est. completion date | November 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Centocor Ortho Biotech Services, L.L.C. |
Fleischmann RM, Cohen SB, Moreland LW, Schiff M, Mease PJ, Smith DB, Keenan G, Kremer JM; iRAMT Study Group. Methotrexate dosage reduction in patients with rheumatoid arthritis beginning therapy with infliximab: the Infliximab Rheumatoid Arthritis Methotr — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy endpoint is the number (%) of patients on a maintenance dose of infliximab who achieve at least 40% improvement from baseline in the combined tender and swollen joint count and tolerate any reduction in MTX dose at Week 54 | |||
Secondary | Sustained improvement in signs and symptoms of RA at Week 54, as measured by the percentage improvement from baseline in ACR20 score. Improvement of the ACR20 core set components at Week 54. |
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