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):
AB Science
ClinicalTrials.gov Identifier:
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: masitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AB Science:

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 ]

Enrollment: 20
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: masitinib 3 mg
masitinib 3 mg/kg/day
Drug: masitinib
3 mg/kg/day oral route
Other Name: AB1010
Experimental: masitinib 6 mg
masitinib 6 mg/kg/day
Drug: masitinib
masitinib 6 mg/kg/day oral route
Other Name: AB1010


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00913432

Sponsors and Collaborators
AB Science
Principal Investigator: Jacques Tebib, MD, PhD CHU de Lyon Sud
  More Information

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00913432     History of Changes
Other Study ID Numbers: AB06010 
Study First Received: June 3, 2009
Last Updated: September 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AB Science:
rheumatoid arthritis
c-kit inhibitor

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2016