NCT00831922

Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects suffering from active RA who have shown an inadequate response to one DMARD including MTX or anti-TNF, after 3 months (12 weeks) of treatment. The safety and efficacy will be evaluated on: Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety Pharmacokinetic profile of AB1010

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	masitinib (AB1010)	3 mg/kg/day
DRUG	masitinib (AB1010)	6 mg/kg/day

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-10-01
• First posted: 2009-01-29
• Last updated: 2018-12-11