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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: masitinib

• Registration Number: NCT00913432
• Lead Sponsor: AB Science

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Study Completion: 2010-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
masitinib 3 mg	masitinib	masitinib 3 mg/kg/day
masitinib 6 mg	masitinib	masitinib 6 mg/kg/day

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology Score 50	week 12

Secondary Outcome Measures

Name	Time	Method
DAS28	week 4, 8 and 12