Masitinib in Refractory Active Rheumatoid Arthritis

Study Overview
=================
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.

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

Conditions
-----------------
Rheumatoid Arthritis (RA)

Intervention / Treatment
-----------------
* Drug: masitinib 3 mg
* Drug: masitinib 6.0 mg
* Drug: methotrexate
* Drug: Placebo (methotrexate)
* Drug: Placebo (masitinib)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: masitinib 3 mg<br>masitinib 3 mg/kg/day, tablets, orally, twice a day | Drug: masitinib 3 mg<br> <br> * Other names: AB1010;Drug: Placebo (methotrexate)<br> <br> |
| Experimental: masitinib 6.0 mg<br>masitinib 6.0 mg/kg/day, tablets, orally, twice a day | Drug: masitinib 6.0 mg<br> <br> * Other names: AB1010;Drug: Placebo (methotrexate)<br> <br> |
| Active Comparator: methotrexate<br>methotrexate at the dose of 15 or 20 mg per week | Drug: methotrexate<br> <br> Drug: Placebo (masitinib)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 |  | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR |  | week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, RA, masitinib, DMARD, methotrexate