Status:
COMPLETED
A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 rhe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00154336
Start Date
July 1 2004
End Date
August 1 2005
Last Update
April 25 2017
Active Locations (15)
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1
Novartis Investigative site
Graz, Austria, 8036
2
Novartis Investigative site
Vienna, Austria, A-1090
3
Novartis Investigative site
Vienna, Austria, A-1130
4
Novartis Investigative site
Winnipeg, Manitoba, Canada, R3A 1M1