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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
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: masitinib (AB1010)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AB Science:

Primary Outcome Measures:
  • rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: September 2004
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831922

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

Additional Information:
Publication on study results  This link exits the ClinicalTrials.gov site

No publications provided by AB Science

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alain Moussy, AB Science
ClinicalTrials.gov Identifier: NCT00831922     History of Changes
Other Study ID Numbers: AB04012
Study First Received: January 28, 2009
Last Updated: August 11, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AB Science:
Rheumatoid Arthritis
DMARD failure
ACR

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

ClinicalTrials.gov processed this record on May 21, 2013