Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

AB Science

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: masitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913432

AB06010

Details and patient eligibility

About

A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
2. ACR functional class I-III
3. Have active RA
4. Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha

Exclusion criteria

1. Patient had a major surgery within 2 weeks prior to study entry.
2. Life expectancy < 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

masitinib 3 mg

Experimental group

Description:

masitinib 3 mg/kg/day

Treatment:

Drug: masitinib

Drug: masitinib

masitinib 6 mg

Experimental group

Description:

masitinib 6 mg/kg/day

Treatment:

Drug: masitinib

Drug: masitinib