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

AB Science20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

masitinibDRUG

3 mg/kg/day oral route

masitinibDRUG

masitinib 6 mg/kg/day oral route

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

American College of Rheumatology Score 50

Time frame: week 12

Secondary Outcomes

DAS28

Time frame: week 4, 8 and 12

Data from ClinicalTrials.gov

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