A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.

Novartis

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Imatinib Placebo

Drug: Methotrexate

Drug: Imatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154336

CSTI571E2201

Details and patient eligibility

About

Imatinib is a member of a new class of drugs known as signal transduction inhibitors. The purpose of this study is to evaluate the efficacy, safety and tolerability of imatinib in the treatment of rheumatoid arthritis in combination with methotrexate in patients who do not respond satisfactorily to standard treatment, e.g. methotrexate.

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.