1. Patient disposition, weeks 24–128.
Patient disposition, weeks 24–128. Reasons for discontinuation include adverse event, lack of efficacy, investigator decision, protocol violation, entry criteria not met, and patient decision. One hundred patients did not enter the first open-label extension (OLE): 42 patients who discontinued during the double-blind period (weeks 0–24) and 58 patients who completed Week 24. Of the 58 eligible patients who did not enter the first OLE, 55 were from sites not participating in the OLE and 3 elected not to participate. Fifty-seven patients did not continue to the second OLE: 32 who discontinued during the first OLE and 25 who completed the first OLE (19 patients from sites not participating in the second OLE and 6 who elected not to participate).
Edward C. Keystone et al. J Rheumatol 2018;45:14-21
©2018 by The Journal of Rheumatology