Rheumatoid ArthritisPhase 2NCT00913432
Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis
A Phase 2 study testing masitinib in people with Rheumatoid Arthritis, run by AB Science.
Trial summary
A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- masitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
- ACR functional class I-III
- Have active RA
- Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha
Who cannot join
- Patient had a major surgery within 2 weeks prior to study entry.
- Life expectancy < 6 months.
About this study
Official title: A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha
A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.
- Conditions
- Rheumatoid Arthritis
- Being tested
- masitinib
- Keywords
- rheumatoid arthritis, methotrexate, DMARD, c-kit inhibitor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
masitinibDrug
Also called AB1010
3 mg/kg/day oral route
masitinibDrug
Also called AB1010
masitinib 6 mg/kg/day oral route
| Study group | Role | What they receive |
|---|---|---|
| masitinib 3 mg | Experimental | masitinib 3 mg/kg/day Receives: Drug: masitinib |
| masitinib 6 mg | Experimental | masitinib 6 mg/kg/day Receives: Drug: masitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology Score 50
Measured: week 12
Secondary outcomes (1)
DAS28
Measured: week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionSep 2010
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.
- 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Tebib, MD, PhD, Principal investigator, CHU de Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913432
- Sponsor's protocol ID
- AB06010
- Status last verified
- Dec 2018
- First submitted
- 3 Jun 2009
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha
- ClinicalTrials.gov ID
- NCT00913432
- Acronym / sponsor ID
- AB06010
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, methotrexate, DMARD, c-kit inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Jun 2009 (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.
A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| masitinib 3 mg | Experimental | Drug: masitinibmasitinib 3 mg/kg/day |
| masitinib 6 mg | Experimental | Drug: masitinibmasitinib 6 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
- ACR functional class I-III
- Have active RA
- Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha
Key exclusion criteria (2 listed)
- Patient had a major surgery within 2 weeks prior to study entry.
- Life expectancy < 6 months.
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 |
|---|---|---|
| masitinibAlso: AB10103 mg/kg/day oral route | Drug | masitinib 3 mg |
| masitinibAlso: AB1010masitinib 6 mg/kg/day oral route | Drug | masitinib 6 mg |
Primary outcome
American College of Rheumatology Score 50
Time frame: week 12
1 secondary outcome
DAS28
Time frame: week 4, 8 and 12
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 13 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, PhD principal investigator
CHU de Lyon Sud
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing masitinib in people with Rheumatoid Arthritis, run by AB Science.
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 2 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
American College of Rheumatology Score 50 (time frame: week 12). 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 13 Dec 2018.