Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments masitinib
Phase phase 2
Sponsor AB Science
Start date March 2007
End date March 2009
Trial size 20 participants
Trial identifier NCT00913432, AB06010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
masitinib 3 mg/kg/day
masitinib AB1010
3 mg/kg/day oral route
(Experimental)
masitinib 6 mg/kg/day
masitinib AB1010
masitinib 6 mg/kg/day oral route

Primary Outcomes

Measure
American College of Rheumatology Score 50
time frame: week 12

Secondary Outcomes

Measure
DAS28
time frame: week 4, 8 and 12

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha
Principal investigator Jacques Tebib, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by AB Science.