Study Stopped
Sponsor decision based on portfolio prioritization
Masitinib in Refractory Active Rheumatoid Arthritis
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
1 other identifier
interventional
324
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 17, 2018
December 1, 2018
4.3 years
August 4, 2011
December 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR50
week 24
Secondary Outcomes (1)
ACR
week 12
Study Arms (3)
masitinib 3 mg
EXPERIMENTALmasitinib 3 mg/kg/day, tablets, orally, twice a day
masitinib 6.0 mg
EXPERIMENTALmasitinib 6.0 mg/kg/day, tablets, orally, twice a day
methotrexate
ACTIVE COMPARATORmethotrexate at the dose of 15 or 20 mg per week
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AB Sciencelead
Study Sites (1)
ARTMEDI UPD s.r.o
Hostivice, 25301, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Tebib, MD
Centre Hospitalier Lyon Sud, Pierre-Bénite, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 5, 2011
Study Start
July 1, 2011
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 17, 2018
Record last verified: 2018-12