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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kakogawa, Hyōgo, Japan
Unnamed facility
Katō, Hyōgo, Japan
Unnamed facility
Kahoku-gun, Ishikawa-ken, Japan
Unnamed facility
Yokohama, Kanagawa, Japan
Unnamed facility
Hamamatsu, Shizuoka, Japan
Unnamed facility
Chuo-Ku, Tokyo, Japan
Unnamed facility
Meguro-Ku, Tokyo, Japan
Unnamed facility
Ōta-ku, Tokyo, Japan
...and 2 more locations
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 52 Weeks
Number of Participants With Positive Anti-E6011 Antibodies Results
Time frame: Up to 52 weeks
Serum Concentrations of E6011
Time frame: At Week 0 (predose), Week 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (postdose)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.