Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
324 participants
INTERVENTIONAL
2011-07-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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masitinib 3 mg
masitinib 3 mg/kg/day, tablets, orally, twice a day
masitinib 3 mg
Placebo (methotrexate)
masitinib 6.0 mg
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
masitinib 6.0 mg
Placebo (methotrexate)
methotrexate
methotrexate at the dose of 15 or 20 mg per week
methotrexate
Placebo (masitinib)
Interventions
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masitinib 3 mg
masitinib 6.0 mg
methotrexate
Placebo (methotrexate)
Placebo (masitinib)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient with ACR functional class I-III
3. Patient who have active RA
4. 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
5. Patient with a disease onset at \> 16 years of age
Exclusion Criteria
2. Patient with documented fibromyalgia
3. Patient with lactose intolerance
4. Patient presenting with cardiac disorders
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Jacques Tebib, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Lyon Sud, Pierre-Bénite, France
Locations
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ARTMEDI UPD s.r.o
Hostivice, , Czechia
Countries
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Other Identifiers
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AB06012
Identifier Type: -
Identifier Source: org_study_id
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