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Rheumatoid Arthritis (RA) | A Phase 2b/3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Methotrexate in Patients With Active Rheumatoid Arthritis With Inadequate Response to Methotrexate or to Any Disease-Modifying Antirheumatic Drug

Rheumatoid Arthritis (RA) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months 2. Patient with ACR functional class I-III 3. Patient who have active RA 4. 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 5. Patient with a disease onset at > 16 years of age Exclusion Criteria: 1. Patient for whom the use of methotrexate is contraindicated as per its SPC 2. Patient with documented fibromyalgia 3. Patient with lactose intolerance 4. Patient presenting with cardiac disorders

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Rheumatoid Arthritis (RA)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:masitinib

Drug:masitinib

Drug:methotrexate

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

masitinib 3 mgmasitinib 3 mg/kg/day, tablets, orally, twice a day

masitinib 4.5mgmasitinib 4.5mg/kg/day, tablets, orally, twice a day

methotrexatemethotrexate at the dose of 15 or 20 mg per week

Study Status

Unknown status

Start Date: July 2011

Completed Date: December 2015

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: ACR50

Secondary Outcome: ACR

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: AB Science

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01410695

Discuss Methotrexate