A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis
Status:
Completed
Trial end date:
2017-07-13
Target enrollment:
Participant gender:
Summary
This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study
is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate
mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011
in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg
group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400
mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011.
Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks
after the initial administration.