Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
AB Science
ClinicalTrials.gov Identifier:
NCT00831922
First received: January 28, 2009
Last updated: August 11, 2009
Last verified: August 2009

January 28, 2009
August 11, 2009
September 2004
October 2006   (final data collection date for primary outcome measure)
rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831922 on ClinicalTrials.gov Archive Site
  • DAS (disease activity score) at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • ACRn at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • improvement of quality of life assessed by SF12 at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis
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)

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: masitinib (AB1010)
    3 mg/kg/day
  • Drug: masitinib (AB1010)
    6 mg/kg/day
  • Experimental: 1
    masitinib (AB1010) 3 mg/kg/day
    Intervention: Drug: masitinib (AB1010)
  • Experimental: 2
    masitinib (AB1010) 6 mg/kg/day
    Intervention: Drug: masitinib (AB1010)
Tebib J, Mariette X, Bourgeois P, Flipo RM, Gaudin P, Le Loët X, Gineste P, Guy L, Mansfield CD, Moussy A, Dubreuil P, Hermine O, Sibilia J. Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study. Arthritis Res Ther. 2009;11(3):R95. Epub 2009 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
Not Provided
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00831922
AB04012
No
Alain Moussy, AB Science
AB Science
Not Provided
Principal Investigator: Xavier Mariette, MD, PhD Hôpital Kremlin Bicêtre, France
AB Science
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP