Rheumatoid Arthritis (RA)Phase 2/3NCT01410695
Masitinib in Refractory Active Rheumatoid Arthritis
A Phase 2/3 study testing masitinib 3 mg, masitinib 6.0 mg and methotrexate in people with Rheumatoid Arthritis (RA), run by AB Science at 1 site in Czechia.
Trial summary
The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- masitinib 3 mg, masitinib 6.0 mg and methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteCzechia
- Study dates
- Jul 2011to Oct 2015
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months
- Patient with ACR functional class I-III
- Patient who have active RA
- Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs
- Patient with a disease onset at > 16 years of age
Who cannot join
- Patient for whom the use of methotrexate is contraindicated as per its SPC
- Patient with documented fibromyalgia
- Patient with lactose intolerance
- Patient presenting with cardiac disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs
The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- masitinib 3 mg, masitinib 6.0 mg, methotrexate, Placebo (methotrexate), Placebo (masitinib)
- Keywords
- Rheumatoid Arthritis, RA, masitinib, DMARD, 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.
masitinib 3 mgDrug
Also called AB1010
masitinib 6.0 mgDrug
Also called AB1010
methotrexateDrug
Placebo (methotrexate)Drug
Placebo (masitinib)Drug
| Study group | Role | What they receive |
|---|---|---|
| masitinib 3 mg | Experimental | masitinib 3 mg/kg/day, tablets, orally, twice a day Receives: Drug: masitinib 3 mg; Drug: Placebo (methotrexate) |
| masitinib 6.0 mg | Experimental | masitinib 6.0 mg/kg/day, tablets, orally, twice a day Receives: Drug: masitinib 6.0 mg; Drug: Placebo (methotrexate) |
| methotrexate | Active comparator | methotrexate at the dose of 15 or 20 mg per week Receives: Drug: methotrexate; Drug: Placebo (masitinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR50
Measured: week 24
Secondary outcomes (1)
ACR
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Sponsor decision based on portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Tebib, MD, Principal investigator, Centre Hospitalier Lyon Sud, Pierre-Bénite, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410695
- Sponsor's protocol ID
- AB06012
- Status last verified
- Dec 2018
- First submitted
- 4 Aug 2011
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs
- ClinicalTrials.gov ID
- NCT01410695
- Acronym / sponsor ID
- AB06012
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, RA, masitinib, DMARD, methotrexate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization
- Enrolment
- 324 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Aug 2011 (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.
The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| masitinib 3 mg | Experimental | Drug: masitinib 3 mg, Drug: Placebo (methotrexate)masitinib 3 mg/kg/day, tablets, orally, twice a day |
| masitinib 6.0 mg | Experimental | Drug: masitinib 6.0 mg, Drug: Placebo (methotrexate)masitinib 6.0 mg/kg/day, tablets, orally, twice a day |
| methotrexate | Active comparator | Drug: methotrexate, Drug: Placebo (masitinib)methotrexate at the dose of 15 or 20 mg per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months
- Patient with ACR functional class I-III
- Patient who have active RA
- Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs
- Patient with a disease onset at > 16 years of age
Key exclusion criteria (4 listed)
- Patient for whom the use of methotrexate is contraindicated as per its SPC
- Patient with documented fibromyalgia
- Patient with lactose intolerance
- Patient presenting with cardiac disorders
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 |
|---|---|---|
| masitinib 3 mgAlso: AB1010 | Drug | masitinib 3 mg |
| masitinib 6.0 mgAlso: AB1010 | Drug | masitinib 6.0 mg |
| methotrexate | Drug | methotrexate |
| Placebo (methotrexate) | Drug | masitinib 3 mg, masitinib 6.0 mg |
| Placebo (masitinib) | Drug | methotrexate |
Primary outcome
ACR50
Time frame: week 24
1 secondary outcome
ACR
Time frame: week 12
Results and safety
The study was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
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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.
Jacques Tebib, MD principal investigator
Centre Hospitalier Lyon Sud, Pierre-Bénite, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing masitinib 3 mg, masitinib 6.0 mg and methotrexate in people with Rheumatoid Arthritis (RA), run by AB Science at 1 site in Czechia.
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 5 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: stopped early, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
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?
ACR50 (time frame: week 24). 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 17 Dec 2018; AzTrials last refreshed its copy on 1 Nov 2026.