The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
380
SHR-1314 injection.
SHR-1314 placebo injection.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGProportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).
Time frame: At the 16th week after administration.
Proportion of participants achieving ASAS 20 (ankylosing spondylitis disease activity score).
Time frame: At the 16th week after administration.
Change in CRP (C-reactive protein) value from baseline.
Time frame: At the 16th week after administration.
AEs (adverse events).
Time frame: Up to 60 weeks after administration.
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