Status:
TERMINATED
Masitinib in Refractory Active Rheumatoid Arthritis
Lead Sponsor:
AB Science
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT01410695
Start Date
July 1 2011
End Date
October 1 2015
Last Update
December 17 2018
Active Locations (1)
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1
ARTMEDI UPD s.r.o
Hostivice, Czechia, 25301