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A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT00913432
First received: June 3, 2009
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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

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

No publications provided

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
methotrexate
DMARD
c-kit inhibitor

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

ClinicalTrials.gov processed this record on May 23, 2013