A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by AB Science.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
First received: June 3, 2009
Last updated: September 25, 2012
Last verified: September 2012
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- American College of Rheumatology Score 50 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- DAS28 [ Time Frame: week 4, 8 and 12 ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||March 2009 (Final data collection date for primary outcome measure)
Experimental: masitinib 3 mg
masitinib 3 mg/kg/day
3 mg/kg/day oral route
Other Name: AB1010
Experimental: masitinib 6 mg
masitinib 6 mg/kg/day
masitinib 6 mg/kg/day oral route
Other Name: AB1010
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
- ACR functional class I-III
- Have active RA
- 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
- Patient had a major surgery within 2 weeks prior to study entry.
- Life expectancy < 6 months.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913432
||Jacques Tebib, MD, PhD
||CHU de Lyon Sud
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 3, 2009
||September 25, 2012
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Keywords provided by AB Science:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Connective Tissue Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Reproductive Control Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors