Rheumatoid ArthritisPhase 2NCT00154336
A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.
A Phase 2 study testing Imatinib and Methotrexate in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 15 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Imatinib and Methotrexate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Jul 2004to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United Kingdom6 sites
Novartis Investigative site
Cannock, Staffordshire, WS11 2XY
Novartis Investigative site
Colchester, CO4 5JL
Novartis Investigative site
Glasgow, G11 6NT
Novartis Investigative site
Manchester, M41 5SL
Multiple Sites
Multiple Cities
Novartis Investigative site
Stoke-on-Trent, ST6 7AG
Canada4 sites
Novartis Investigative site
Montreal, Quebec, H3Z 2Z3
Novartis Investigative site
Sainte-Foy, Quebec, G1W 4R4
Novartis Investigative site
Toronto, Ontario, M5G 1X5
Novartis Investigative site
Winnipeg, Manitoba, R3A 1M1
Austria3 sites
Novartis Investigative site
Graz, 8036
Novartis Investigative site
Vienna, A-1090
Novartis Investigative site
Vienna, A-1130
Finland2 sites
Novartis Investigative site
Helsinki, 00260
Novartis Investigative site
Husu, 00029
About this study
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).
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Imatinib, Methotrexate, Imatinib Placebo
- Keywords
- Rheumatoid arthritis, imatinib, methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
MethotrexateDrug
Imatinib PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Imatinib 400mmg OD +MTX | Active comparator | Not described Receives: Drug: Imatinib; Drug: Methotrexate |
| Imatinib Placebo + MTX | Placebo comparator | Not described Receives: Drug: Methotrexate; Drug: Imatinib Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154336
- Sponsor's protocol ID
- CSTI571E2201
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2005
- Last updated
- 25 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00154336
- Acronym / sponsor ID
- CSTI571E2201
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, imatinib, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004 (actual)
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imatinib 400mmg OD +MTX | Active comparator | Drug: Imatinib, Drug: Methotrexate |
| Imatinib Placebo + MTX | Placebo comparator | Drug: Methotrexate, Drug: Imatinib Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib | Drug | Imatinib 400mmg OD +MTX |
| Methotrexate | Drug | Imatinib 400mmg OD +MTX, Imatinib Placebo + MTX |
| Imatinib Placebo | Drug | Imatinib Placebo + MTX |
Primary outcome
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.
10 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib and Methotrexate in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, Canada, Austria, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.