A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.
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).
1 other identifier
interventional
50
4 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Jul 2004
Shorter than P25 for phase_2 rheumatoid-arthritis
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedApril 25, 2017
April 1, 2017
1.1 years
September 8, 2005
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Secondary Outcomes (10)
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
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
- +5 more secondary outcomes
Study Arms (2)
Imatinib 400mmg OD +MTX
ACTIVE COMPARATORImatinib Placebo + MTX
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Novartis Investigative site
Graz, 8036, Austria
Novartis Investigative site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
July 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
April 25, 2017
Record last verified: 2017-04