A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.
NCT ID: NCT00154336
Last Updated: 2017-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2004-07-31
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Imatinib 400mmg OD +MTX
Imatinib
Methotrexate
Imatinib Placebo + MTX
Methotrexate
Imatinib Placebo
Interventions
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Imatinib
Methotrexate
Imatinib Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative site
Graz, , Austria
Novartis Investigative site
Vienna, , Austria
Novartis Investigative site
Vienna, , Austria
Novartis Investigative site
Winnipeg, Manitoba, Canada
Novartis Investigative site
Toronto, Ontario, Canada
Novartis Investigative site
Montreal, Quebec, Canada
Novartis Investigative site
Sainte-Foy, Quebec, Canada
Novartis Investigative site
Helsinki, , Finland
Novartis Investigative site
Husu, , Finland
Novartis Investigative site
Cannock, Staffordshire, United Kingdom
Novartis Investigative site
Colchester, , United Kingdom
Novartis Investigative site
Glasgow, , United Kingdom
Novartis Investigative site
Manchester, , United Kingdom
Multiple Sites
Multiple Cities, , United Kingdom
Novartis Investigative site
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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CSTI571E2201
Identifier Type: -
Identifier Source: org_study_id
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