A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, imatinib, methotrexate
Eligibility Criteria
Inclusion Criteria: With a diagnosis of RA classified by ACR 1987 revised criteria with symptoms for at least 6 months Functional status class I, II, III according to the ACR 1991 revised classification criteria Patients have to have been treated with MTX at the maximum tolerated dose for at least 3 months, and be on a stable dose and route of administration for at least 2 months prior to study entry Disease activity criteria of minimum 6 out of 28 tender and swollen joints at baseline Exclusion Criteria: With current use of DMARDs other than MTX. DMARDs include but are not limited to: biologic agents, thiolates (D-penicillamine, thiopronine), sulfasalazine, gold compounds, antimalarials, cyclosporine A, azathioprine, leflunomide and alkylating agents such as cyclophosphamide With any DMRAD treatment used in combination with methotrexate within 1 month prior to study entry. In case of infliximab and leflunomide, a washout period of 2 months is required With any therapy by intra-articular injection, including intra-articular corticosteroid use within 1 month prior to study entry Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Multiple Sites
- Novartis Investigative site
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Imatinib 400mmg OD +MTX
Imatinib Placebo + MTX