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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00246064
Date of registration: 28/10/2005
Prospective Registration: No
Primary sponsor: Centocor Ortho Biotech Services, L.L.C.
Public title: The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol
Scientific title: The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol. Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With Infliximab
Date of first enrolment: December 2001
Target sample size: 210
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Name:     Centocor Ortho Biotech Services, L.L.C. Clinical Trial
Affiliation:  Centocor Ortho Biotech Services, L.L.C.
Key inclusion & exclusion 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

- 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Drug: infliximab
Primary Outcome(s)
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 Outcome(s)
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.
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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