Rheumatoid Arthritis Clinical Trial
Official title:
Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective
This study is in two stages:
Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in
patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not
enough effective.
Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected
TAB08 dose in extended patient population with active Rheumatoid Arthritis in which
methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.
Stage 1 is designed as standard phase 1 study with one arm and sequential dose cohorts with
ascending doses. Each patient in each dose cohort will be administered TAB08 several times.
After last TAB08 administration each patient will undergo investigational-treatment-free
follow-up period.
At Stage 2 at least one TAB08 dose, selected during Stage 1 will be studied during longer
timeframe in extended patient population.
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