Trial | NCT00831922  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    masitinib ...

  • Study Participants

    43
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
Study Started
Sep 30
2004
Primary Completion
Oct 31
2006
Last Update
Dec 11
2018

Drug masitinib (AB1010)

3 mg/kg/day

Drug masitinib (AB1010)

6 mg/kg/day

1 Experimental

masitinib (AB1010) 3 mg/kg/day

2 Experimental

masitinib (AB1010) 6 mg/kg/day

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
No Results Posted