Back to resultsMasitinib in Refractory Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis (RA)
Status
Terminated
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
masitinib 3 mg
masitinib 6.0 mg
methotrexate
Placebo (methotrexate)
Placebo (masitinib)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Rheumatoid Arthritis, RA, masitinib, DMARD, methotrexate
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- ARTMEDI UPD s.r.o
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
masitinib 3 mg
masitinib 6.0 mg
methotrexate
Arm Description
masitinib 3 mg/kg/day, tablets, orally, twice a day
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
methotrexate at the dose of 15 or 20 mg per week
Outcomes
Primary Outcome Measures
ACR50
Secondary Outcome Measures
ACR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01410695
Brief Title
Masitinib in Refractory Active Rheumatoid Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Rheumatoid Arthritis, RA, masitinib, DMARD, methotrexate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
masitinib 3 mg
Arm Type
Experimental
Arm Description
masitinib 3 mg/kg/day, tablets, orally, twice a day
Arm Title
masitinib 6.0 mg
Arm Type
Experimental
Arm Description
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
Arm Title
methotrexate
Arm Type
Active Comparator
Arm Description
methotrexate at the dose of 15 or 20 mg per week
Intervention Type
Drug
Intervention Name(s)
masitinib 3 mg
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
masitinib 6.0 mg
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
Placebo (methotrexate)
Intervention Type
Drug
Intervention Name(s)
Placebo (masitinib)
Primary Outcome Measure Information:
Title
ACR50
Time Frame
week 24
Secondary Outcome Measure Information:
Title
ACR
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Tebib, MD
Organizational Affiliation
Centre Hospitalier Lyon Sud, Pierre-Bénite, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
ARTMEDI UPD s.r.o
City
Hostivice
ZIP/Postal Code
25301
Country
Czechia
12. IPD Sharing Statement
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Masitinib in Refractory Active Rheumatoid Arthritis
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