This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
174
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose
Inha University Hospital
Incheon, South Korea
Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test
Time frame: Up to Week 40
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