Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects suffering from active RA who have shown an inadequate response to one DMARD including MTX or anti-TNF, after 3 months (12 weeks) of treatment. The safety and efficacy will be evaluated on: Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety Pharmacokinetic profile of AB1010

Official Title
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A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: masitinib (AB1010)
* Drug: masitinib (AB1010)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet American College of Rheumatology (ACR) criteria for RA Have active RA ACR functional class I-III Disease onset at > 16 years of age Disease duration of at least 6 months Failure to one DMARD including methotrexate and anti-TNF alpha Exclusion Criteria: Pregnant or breastfeeding women Inadequate bone marrow function Current use of a DMARD within 4 weeks (or 5 half-lives, whichever is longer) of screening except for leflunomide which requires a specific wash-out Any previous use of recombinant IL1-Ra Current use of more than 1 non steroidal anti-inflammatory drug (NSAID) or change of dose of the NSAID within 4 weeks of baseline or NSAID use greater than the maximum recommended dose Within 4 weeks before baseline, use of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (>20 mg prednisone or equivalent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>masitinib (AB1010) 3 mg/kg/day | Drug: masitinib (AB1010)<br>* 3 mg/kg/day<br>|
| Experimental: 2<br>masitinib (AB1010) 6 mg/kg/day | Drug: masitinib (AB1010)<br>* 6 mg/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS (disease activity score) at 12 weeks |  | 12 weeks | 
| ACRn at 12 weeks |  | 12 weeks | 
| improvement of quality of life assessed by SF12 at 12 weeks |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACR, Rheumatoid Arthritis, DMARD failure