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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by AB Science
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01410695
First received: August 4, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ACR [ Time Frame: week 12 ] [ Designated as safety issue: No ]

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01410695

Contacts
Contact: Jacques Tebib, MD jacques.tebib@chu-lyon.fr

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

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01410695     History of Changes
Other Study ID Numbers: AB06012
Study First Received: August 4, 2011
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AB Science:
Rheumatoid Arthritis
RA
masitinib
DMARD
methotrexate

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

ClinicalTrials.gov processed this record on October 21, 2014