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Completed

NCT Number: NCT00154336

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

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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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative site, Graz, Austria

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imatinib

Drug

methotrexate

Drug

Imatinib Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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).

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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