Masitinib in Refractory Active Rheumatoid Arthritis

AB Science

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: methotrexate; Drug: masitinib 6.0 mg; Drug: Placebo (methotrexate); Drug: Placebo (masitinib); Drug: masitinib 3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410695

AB06012

Details and patient eligibility

About

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.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 3 patient groups

masitinib 3 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo (methotrexate)

Drug: masitinib 3 mg

masitinib 6.0 mg

Experimental group

Description:

masitinib 6.0 mg/kg/day, tablets, orally, twice a day

Treatment:

Drug: Placebo (methotrexate)

Drug: masitinib 6.0 mg

methotrexate

Active Comparator group

Description:

methotrexate at the dose of 15 or 20 mg per week

Treatment:

Drug: Placebo (masitinib)

Drug: methotrexate