This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites.
The study is divided into two stages, the first stage (1-16 weeks) is the main study; the second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
Morning: 2\*50mg simulated tablets and 1\*75mg Jaktinib Hydrochloride Tablets; Evening: 2\*50mg simulated tablets and 1\*75mg Jaktinib Hydrochloride Tablets.
Morning: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets; Evening: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets.
Morning: 1\*75mg simulated tablet, 2\*50mg simulated tablets; Evening: 1\*75mg simulated tablet, 2\*50mg simulated tablets.
Renji Hospital
Shanghai, Shanghai Municipality, China
Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Time frame: Week 16
Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32
It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.The score range was 0-10, the low score meant that the spinal movement was better.
Time frame: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32
ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Time frame: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32
It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The score range was 0-10, the low score meant that the spinal movement was better.
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Time frame: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32
ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Time frame: Week 2,4,8,12,16,20,24,32