Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	AB Science
Information provided by:	AB Science
ClinicalTrials.gov Identifier:	NCT00831922

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 II

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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)

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
1: Experimental masitinib (AB1010) 3 mg/kg/day	Drug: masitinib (AB1010) 3 mg/kg/day
2: Experimental 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:

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

Exclusion Criteria:

Pregnant or breastfeeding women
Inadequate bone marrow function
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
Any previous use of recombinant IL1-Ra
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
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

No publications provided

Responsible Party:	AB Science ( Alain Moussy )
Study ID Numbers:	AB04012
Study First Received:	January 28, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00831922 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by AB Science:

Rheumatoid Arthritis
DMARD failure
ACR

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Therapeutic Uses
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009