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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib 400mmg OD +MTX | Active Comparator |
| |
| Imatinib Placebo + MTX | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug |
| ||
| Methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of imatinib in combination with MTX in pts with active RA by assessing response to treatment(ACR20) after 3 mos compared to MTX alone | ||
| Overall safety and tolerability of imatinib in combination with MTX in pts with active RA over 3 mos compared to MTX alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of imatinib in combination with MTX by assessing the response to treatment (ACR50 and ACR70 criteria; DAS28/EULAR28) after 3 mos compared to MTX alone | ||
| Effect of imatinib in combination with MTX on ACR components after 3 mos compared to MTX alone |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Graz | 8036 | Austria | |||
| Novartis Investigative site |
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|
| Imatinib Placebo | Drug |
|
| Effect of imatinib in combination with MTX on rheumatoid factor concentrations |
| Determine time of onset of clinical response to imatinib in combination with MTX |
| Determine retention on treatment of imatinib in combination with MTX over 3 mos |
| Assess pt's quality of life by means of the Euro QoL 50 Health Questionnaire |
| Assess in a subset of pts pharmacokinetics of imatinib and MTX and their potential interactions when co-administered |
| Assess pharmacodynamic effect of imatinib in combination with MTX on liver enzymes, hematology and kidney function |
| Explore potential for RA and drug-specific biomarkers |
| Explore decrease in synovitis by means of ultrasound in a sub-set of patients. |
| Vienna |
| A-1090 |
| Austria |
| Novartis Investigative site | Vienna | A-1130 | Austria |
| Novartis Investigative site | Winnipeg | Manitoba | R3A 1M1 | Canada |
| Novartis Investigative site | Toronto | Ontario | M5G 1X5 | Canada |
| Novartis Investigative site | Montreal | Quebec | H3Z 2Z3 | Canada |
| Novartis Investigative site | Sainte-Foy | Quebec | G1W 4R4 | Canada |
| Novartis Investigative site | Helsinki | 00260 | Finland |
| Novartis Investigative site | Husu | 00029 | Finland |
| Novartis Investigative site | Cannock | Staffordshire | WS11 2XY | United Kingdom |
| Novartis Investigative site | Colchester | CO4 5JL | United Kingdom |
| Novartis Investigative site | Glasgow | G11 6NT | United Kingdom |
| Novartis Investigative site | Manchester | M41 5SL | United Kingdom |
| Multiple Sites | Multiple Cities | United Kingdom |
| Novartis Investigative site | Stoke-on-Trent | ST6 7AG | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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