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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
3 mg/kg/day
6 mg/kg/day
rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks
Time frame: 12 weeks
DAS (disease activity score) at 12 weeks
Time frame: 12 weeks
ACRn at 12 weeks
Time frame: 12 weeks
improvement of quality of life assessed by SF12 at 12 weeks
Time frame: 12 weeks
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