A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
Status:
Completed
Trial end date:
2016-10-14
Target enrollment:
Participant gender:
Summary
This randomized, multicenter, double-blind, parallel group study will evaluate the impact of
MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active
rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants
will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose
orally in an open-label manner for 24 weeks. Participants with a disease activity score based
on 28 joints (DAS28) less than or equal to (=) 3.2 at Week 24, will be randomized to either
continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52.
Participants without a DAS28 score =3.2 at Week 24, will continue the same treatment in a
non-randomized open-label manner up to Week 52.