Rheumatoid Arthritis Clinical Trial
Official title:
Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation
The objective of this study is to investigate the efficacy and safety of the humanized
anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in
combination therapy with methotrexate (MTX) in patients with an inadequate response to
treatment with MTX.
Furthermore, in patients who have been able to achieve control of disease activity via the
above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is
restarted after disease recurrence.
In this study, we aim to prospectively and randomly evaluate efficacy for changes in clinical remission and joint destruction in RA patients in treatment with TCZ monotherapy(SWITCH) and in combination therapy with MTX(ADD-ON), and also to investigate the best therapeutic approach to achieve discontinuation. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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