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

Rheumatoid Arthritis Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154336
• Other study ID #: CSTI571E2201
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: April 24, 2017
• Start date: July 2004
• Est. completion date: August 2005

Study information

• Verified date: April 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Imatinib

• Methotrexate

• Imatinib Placebo

Locations

Country	Name	City	State
Austria	Novartis Investigative site	Graz
Austria	Novartis Investigative site	Vienna
Austria	Novartis Investigative site	Vienna
Canada	Novartis Investigative site	Montréal	Quebec
Canada	Novartis Investigative site	Sainte-Foy	Quebec
Canada	Novartis Investigative site	Toronto	Ontario
Canada	Novartis Investigative site	Winnipeg	Manitoba
Finland	Novartis Investigative site	Helsinki
Finland	Novartis Investigative site	Husu
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Canada,  Finland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall safety and tolerability of imatinib in combination with MTX in pts with active RA over 3 mos compared to MTX alone.
Secondary	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
Secondary	Effect of imatinib in combination with MTX on ACR components after 3 mos compared to MTX alone
Secondary	Effect of imatinib in combination with MTX on rheumatoid factor concentrations
Secondary	Determine time of onset of clinical response to imatinib in combination with MTX
Secondary	Determine retention on treatment of imatinib in combination with MTX over 3 mos
Secondary	Assess pt's quality of life by means of the Euro QoL 50 Health Questionnaire
Secondary	Assess in a subset of pts pharmacokinetics of imatinib and MTX and their potential interactions when co-administered
Secondary	Assess pharmacodynamic effect of imatinib in combination with MTX on liver enzymes, hematology and kidney function
Secondary	Explore potential for RA and drug-specific biomarkers
Secondary	Explore decrease in synovitis by means of ultrasound in a sub-set of patients.