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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00913432
Recruitment Status : Unknown
Verified September 2012 by AB Science.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2009
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: masitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Primary Completion Date : March 2009
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. American College of Rheumatology Score 50 [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. DAS28 [ Time Frame: week 4, 8 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913432


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

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00913432     History of Changes
Other Study ID Numbers: AB06010
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

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
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