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Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
masitinib
masitinib
Sponsored by
AB Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, methotrexate, DMARD, c-kit inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    masitinib 3 mg

    masitinib 6 mg

    Arm Description

    masitinib 3 mg/kg/day

    masitinib 6 mg/kg/day

    Outcomes

    Primary Outcome Measures

    American College of Rheumatology Score 50

    Secondary Outcome Measures

    DAS28

    Full Information

    First Posted
    June 3, 2009
    Last Updated
    December 12, 2018
    Sponsor
    AB Science
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00913432
    Brief Title
    Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AB Science

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    rheumatoid arthritis, methotrexate, DMARD, c-kit inhibitor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    masitinib 3 mg
    Arm Type
    Experimental
    Arm Description
    masitinib 3 mg/kg/day
    Arm Title
    masitinib 6 mg
    Arm Type
    Experimental
    Arm Description
    masitinib 6 mg/kg/day
    Intervention Type
    Drug
    Intervention Name(s)
    masitinib
    Other Intervention Name(s)
    AB1010
    Intervention Description
    3 mg/kg/day oral route
    Intervention Type
    Drug
    Intervention Name(s)
    masitinib
    Other Intervention Name(s)
    AB1010
    Intervention Description
    masitinib 6 mg/kg/day oral route
    Primary Outcome Measure Information:
    Title
    American College of Rheumatology Score 50
    Time Frame
    week 12
    Secondary Outcome Measure Information:
    Title
    DAS28
    Time Frame
    week 4, 8 and 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA. ACR functional class I-III Have active RA 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: Patient had a major surgery within 2 weeks prior to study entry. Life expectancy < 6 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jacques Tebib, MD, PhD
    Organizational Affiliation
    CHU de Lyon Sud
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

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