Efficacy of Oral AB1010 in Adult 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. Identifier: NCT00831922
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : August 12, 2009
Information provided by:
AB Science

Brief Summary:

The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects suffering from active RA who have shown an inadequate response to one DMARD including MTX or anti-TNF, after 3 months (12 weeks) of treatment.

The safety and efficacy will be evaluated on:

Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety Pharmacokinetic profile of AB1010

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: masitinib (AB1010) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)
Study Start Date : September 2004
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
masitinib (AB1010) 3 mg/kg/day
Drug: masitinib (AB1010)
3 mg/kg/day
Experimental: 2
masitinib (AB1010) 6 mg/kg/day
Drug: masitinib (AB1010)
6 mg/kg/day

Primary Outcome Measures :
  1. rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. DAS (disease activity score) at 12 weeks [ Time Frame: 12 weeks ]
  2. ACRn at 12 weeks [ Time Frame: 12 weeks ]
  3. improvement of quality of life assessed by SF12 at 12 weeks [ Time Frame: 12 weeks ]

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

Inclusion Criteria:

  1. Meet American College of Rheumatology (ACR) criteria for RA
  2. Have active RA
  3. ACR functional class I-III
  4. Disease onset at > 16 years of age
  5. Disease duration of at least 6 months
  6. Failure to one DMARD including methotrexate and anti-TNF alpha

Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. Inadequate bone marrow function
  3. Current use of a DMARD within 4 weeks (or 5 half-lives, whichever is longer) of screening except for leflunomide which requires a specific wash-out
  4. Any previous use of recombinant IL1-Ra
  5. Current use of more than 1 non steroidal anti-inflammatory drug (NSAID) or change of dose of the NSAID within 4 weeks of baseline or NSAID use greater than the maximum recommended dose
  6. Within 4 weeks before baseline, use of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (>20 mg prednisone or equivalent

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 identifier (NCT number): NCT00831922

Sponsors and Collaborators
AB Science
Principal Investigator: Xavier Mariette, MD, PhD Hôpital Kremlin Bicêtre, France

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alain Moussy, AB Science Identifier: NCT00831922     History of Changes
Other Study ID Numbers: AB04012
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009

Keywords provided by AB Science:
Rheumatoid Arthritis
DMARD failure

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents