The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and long term safety up to Week 48。 The main question it aims to answer is whether GR1501 injection was superior to placebo in the proportion of subjects with ASAS20 response at week 16 in patients with Radiographic Axial Spondyloarthritis.
This is a randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of GR1501 injection in Radiographic Axial Spondyloarthritis, as well as a confirmatory clinical trial of immunogenicity. This clinical trial was divided into four stages, namely screening period (W-4\~W0), core treatment period (W0\~W16), maintenance treatment period (W16\~W32), and follow-up period (W32\~W48). target population： radiographic axial spondyloarthritis who had a inadequate response to NSAIDs or have a history of intolerance to NSAIDs. primary outcome measure:percentage of participants achieving an ASAS20 response in week 16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
465
3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly
3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly
* Core treatment period:placebo * Maintenance treatment period: GR1501 injection
Peking union Medical Hosipital
Beijing, Beijing Municipality, China
The Proportion of Participants Who Achieve an ASAS 20 Response
ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains
Time frame: week 16
The Proportion of Participants Who Achieve an ASAS 20 Response
ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains
Time frame: week 2 to 48
The Proportion of Participants Who Achieve an ASAS 40 Response
ASAS40 response is defined as an improvement of ≥40% and ≥2 units in at least three of the four ASAS main domains
Time frame: week 2 to 48
The Proportion of Participants Who Achieve an ASAS 5/6 Response
The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains
Time frame: week 16，32，48
Change From Baseline in Mobility on the BASMI
5 clinical measurements Bath Ankylosing Spondylitis Metrology Index
Time frame: week 16，32，48
Change From Baseline in BASDAI Response
6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis
Time frame: week 16，32，48
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities
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Time frame: week 16，32，48
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity
Time frame: week 16，32，48
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in AS
Time frame: week 16，32，48