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A Phase 2b/3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Methotrexate in Patients With Active Rheumatoid Arthritis With Inadequate Response to Methotrexate or to Any Disease-Modifying Antirheumatic Drug

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by AB Science.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
AB Science Identifier:
First received: August 4, 2011
Last updated: August 13, 2013
Last verified: August 2013
The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.

Condition Intervention Phase
Rheumatoid Arthritis (RA) Drug: masitinib Drug: methotrexate Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs

Resource links provided by NLM:

Further study details as provided by AB Science:

Primary Outcome Measures:
  • ACR50 [ Time Frame: week 24 ]

Secondary Outcome Measures:
  • ACR [ Time Frame: week 12 ]

Estimated Enrollment: 450
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: masitinib 3 mg
masitinib 3 mg/kg/day, tablets, orally, twice a day
Drug: masitinib
Experimental: masitinib 4.5mg
masitinib 4.5mg/kg/day, tablets, orally, twice a day
Drug: masitinib
Active Comparator: methotrexate
methotrexate at the dose of 15 or 20 mg per week
Drug: methotrexate


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months
  2. Patient with ACR functional class I-III
  3. Patient who have active RA
  4. Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs
  5. Patient with a disease onset at > 16 years of age

Exclusion Criteria:

  1. Patient for whom the use of methotrexate is contraindicated as per its SPC
  2. Patient with documented fibromyalgia
  3. Patient with lactose intolerance
  4. Patient presenting with cardiac disorders
  Contacts and Locations
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 identifier: NCT01410695

Contact: Jacques Tebib, MD

Czech Republic
ARTMEDI UPD s.r.o Recruiting
Hostivice, Czech Republic, 25301
Sponsors and Collaborators
AB Science
  More Information

Responsible Party: AB Science Identifier: NCT01410695     History of Changes
Other Study ID Numbers: AB06012
Study First Received: August 4, 2011
Last Updated: August 13, 2013

Keywords provided by AB Science:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors processed this record on September 19, 2017