Clinical trial NCT00154336: A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis, imatinib, methotrexate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
measure: Overall safety and tolerability of imatinib in combination with MTX in pts with active RA over 3 mos compared to MTX alone.
Secondary outcomes:
measure: 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
measure: Effect of imatinib in combination with MTX on ACR components after 3 mos compared to MTX alone
measure: Effect of imatinib in combination with MTX on rheumatoid factor concentrations
measure: Determine time of onset of clinical response to imatinib in combination with MTX
measure: Determine retention on treatment of imatinib in combination with MTX over 3 mos
measure: Assess pt's quality of life by means of the Euro QoL 50 Health Questionnaire
measure: Assess in a subset of pts pharmacokinetics of imatinib and MTX and their potential interactions when co-administered
measure: Assess pharmacodynamic effect of imatinib in combination with MTX on liver enzymes, hematology and kidney function
measure: Explore potential for RA and drug-specific biomarkers
measure: Explore decrease in synovitis by means of ultrasound in a sub-set of patients.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novartis Investigative site
city: Vienna
country: Austria
facility: Novartis Investigative site
city: Vienna
country: Austria
facility: Novartis Investigative site
city: Winnipeg
country: Canada
facility: Novartis Investigative site
state: Manitoba
city: Toronto
country: Canada
facility: Novartis Investigative site
state: Ontario
city: Montréal
country: Canada
facility: Novartis Investigative site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Novartis Investigative site
state: Quebec
city: Helsinki
country: Finland
facility: Novartis Investigative site
city: Husu
country: Finland
facility: Novartis Investigative site
city: Cannock
country: United Kingdom
facility: Novartis Investigative site
state: Staffordshire
city: Colchester
country: United Kingdom
facility: Novartis Investigative site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative site
city: Manchester
country: United Kingdom
facility: Novartis Investigative site
city: Multiple Cities
country: United Kingdom
facility: Multiple Sites
city: Stoke-on-Trent
country: United Kingdom
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: