Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

Sponsor
AB Science
Study ID
NCT00831922
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Sep 30, 2004
Status verified
Dec 2018
Primary completion
Oct 31, 2006

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    masitinib (AB1010) 3 mg/kg/day
  • Experimental: 2
    masitinib (AB1010) 6 mg/kg/day

Primary Outcome Measure

rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks [ Time Frame: 12 weeks ]

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