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

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ClinicalTrials.gov Identifier: NCT00154336
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 rheumatoid arthritis in combination with methotrexate in patients who do not respond satisfactorily to standard treatment, e.g. methotrexate.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Imatinib Drug: Methotrexate Drug: Imatinib Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 3-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety & Tolerability of Imatinib 400 mg Daily in Combination With Methotrexate (MTX)Compared to MTX Alone in the Treatment of Rheumatoid Arthritis (RA).
Actual Study Start Date : July 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Imatinib 400mmg OD +MTX Drug: Imatinib
Drug: Methotrexate
Placebo Comparator: Imatinib Placebo + MTX Drug: Methotrexate
Drug: Imatinib Placebo



Primary Outcome Measures :
  1. 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
  2. Overall safety and tolerability of imatinib in combination with MTX in pts with active RA over 3 mos compared to MTX alone.

Secondary Outcome Measures :
  1. 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
  2. Effect of imatinib in combination with MTX on ACR components after 3 mos compared to MTX alone
  3. Effect of imatinib in combination with MTX on rheumatoid factor concentrations
  4. Determine time of onset of clinical response to imatinib in combination with MTX
  5. Determine retention on treatment of imatinib in combination with MTX over 3 mos
  6. Assess pt's quality of life by means of the Euro QoL 50 Health Questionnaire
  7. Assess in a subset of pts pharmacokinetics of imatinib and MTX and their potential interactions when co-administered
  8. Assess pharmacodynamic effect of imatinib in combination with MTX on liver enzymes, hematology and kidney function
  9. Explore potential for RA and drug-specific biomarkers
  10. Explore decrease in synovitis by means of ultrasound in a sub-set of patients.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154336


Locations
Austria
Novartis Investigative site
Graz, Austria, 8036
Novartis Investigative site
Vienna, Austria, A-1090
Novartis Investigative site
Vienna, Austria, A-1130
Canada, Manitoba
Novartis Investigative site
Winnipeg, Manitoba, Canada, R3A 1M1
Canada, Ontario
Novartis Investigative site
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Novartis Investigative site
Montréal, Quebec, Canada, H3Z 2Z3
Novartis Investigative site
Sainte-Foy, Quebec, Canada, G1W 4R4
Finland
Novartis Investigative site
Helsinki, Finland, 00260
Novartis Investigative site
Husu, Finland, 00029
United Kingdom
Novartis Investigative site
Cannock, Staffordshire, United Kingdom, WS11 2XY
Novartis Investigative site
Colchester, United Kingdom, CO4 5JL
Novartis Investigative site
Glasgow, United Kingdom, G11 6NT
Novartis Investigative site
Manchester, United Kingdom, M41 5SL
Multiple Sites
Multiple Cities, United Kingdom
Novartis Investigative site
Stoke-on-Trent, United Kingdom, ST6 7AG
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00154336     History of Changes
Other Study ID Numbers: CSTI571E2201
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Rheumatoid arthritis, imatinib, methotrexate

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Imatinib Mesylate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors