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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Imatinib
Methotrexate
Imatinib Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, imatinib, methotrexate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Multiple Sites
  • Novartis Investigative site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Imatinib 400mmg OD +MTX

Imatinib Placebo + MTX

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

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
Assess pt's quality of life by means of the Euro QoL 50 Health Questionnaire
Assess in a subset of pts pharmacokinetics of imatinib and MTX and their potential interactions when co-administered
Assess pharmacodynamic effect of imatinib in combination with MTX on liver enzymes, hematology and kidney function
Explore potential for RA and drug-specific biomarkers
Explore decrease in synovitis by means of ultrasound in a sub-set of patients.

Full Information

First Posted
September 8, 2005
Last Updated
April 24, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00154336
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (Actual)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, imatinib, methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imatinib 400mmg OD +MTX
Arm Type
Active Comparator
Arm Title
Imatinib Placebo + MTX
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Imatinib Placebo
Primary Outcome Measure Information:
Title
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
Title
Overall safety and tolerability of imatinib in combination with MTX in pts with active RA over 3 mos compared to MTX alone.
Secondary Outcome Measure Information:
Title
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
Title
Effect of imatinib in combination with MTX on ACR components after 3 mos compared to MTX alone
Title
Effect of imatinib in combination with MTX on rheumatoid factor concentrations
Title
Determine time of onset of clinical response to imatinib in combination with MTX
Title
Determine retention on treatment of imatinib in combination with MTX over 3 mos
Title
Assess pt's quality of life by means of the Euro QoL 50 Health Questionnaire
Title
Assess in a subset of pts pharmacokinetics of imatinib and MTX and their potential interactions when co-administered
Title
Assess pharmacodynamic effect of imatinib in combination with MTX on liver enzymes, hematology and kidney function
Title
Explore potential for RA and drug-specific biomarkers
Title
Explore decrease in synovitis by means of ultrasound in a sub-set of patients.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novartis Investigative site
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Novartis Investigative site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
Novartis Investigative site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M1
Country
Canada
Facility Name
Novartis Investigative site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Novartis Investigative site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3Z 2Z3
Country
Canada
Facility Name
Novartis Investigative site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Novartis Investigative site
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Novartis Investigative site
City
Husu
ZIP/Postal Code
00029
Country
Finland
Facility Name
Novartis Investigative site
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 2XY
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Manchester
ZIP/Postal Code
M41 5SL
Country
United Kingdom
Facility Name
Multiple Sites
City
Multiple Cities
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Stoke-on-Trent
ZIP/Postal Code
ST6 7AG
Country
United Kingdom

12. IPD Sharing Statement

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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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