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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 : Completed
First Posted : June 4, 2009
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

Study Description
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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 Design
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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
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Contacts and Locations
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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
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Principal Investigator: Jacques Tebib, MD, PhD CHU de Lyon Sud
More Information
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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00913432    
Other Study ID Numbers: AB06010
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AB Science:
rheumatoid arthritis
methotrexate
DMARD
c-kit inhibitor
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases