Ankylosing spondylitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily signed the informed consent form; 2. Age 18~70 years old, male or female; 3. Adopt the AS New York standard, which was revised in 1984. For those who do not meet this criterion temporarily, please refer to the classification criteria for SpA, the classification criteria for axial SpA recommended by ASAS in 2009. The New York criteria for AS revised in 1984: (1) low back pain persists for at least 3 months, and the pain improves with activity, but does not decrease with rest; (2) limited movement of the lumbar spine in anterior, anterior and lateral flexion directions; (3) the range of thoracic extension is less than the normal value of the same age and sex; (4) Bilateral sacroiliitis grade II.-IV., or unilateral sacroiliitis grade III.-IV. If the patient has (4) and appends any one of the (1)-(3) criteria, respectively, the diagnosis of AS can be confirmed. The classification criteria for axial SpA recommended by ASAS in 2009 are: patients with onset age 3 months, plus one of the following criteria: (1) imaging suggestive of sacroiliitis plus >= one of the following SpA features; (2) HLA-B27 positivity plus >= 2 other SpA features described below. Radiographic findings of sacroiliitis refer to: (1) active (acute) inflammation of the sacroiliac joint on MRI, high suggestive of sacroiliitis associated with SpA, or (2) definite radiographic changes in sacroiliitis (according to the New York criteria revised in 1984). SpA features include: (1) inflammatory back pain; (2) arthritis; (3) enthesitis (Achilles tendon); (4) ocular uveitis; (5) dactylitis; (6) psoriasis; (7) Crohn's disease/ulcerative colitis; (8) Good response to non-steroidal anti-inflammatory drugs (NSAIDs); (9) family history of SpA; (10) HLA-B27 positive; CRP is elevated.
Exclusion criteria
Exclusion criteria: (1) Those with complete ankylosis of the spine; (2) Other systemic inflammatory disease (including, but not limited to, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, etc.) at the time of screening, or other disease that, in the judgment of the investigator, may interfere with evaluation of the effectiveness of treatment. (3) Other active inflammatory disease (including but not limited to active Crohn's disease, active ulcerative colitis, or other active inflammatory bowel disease) at the time of screening. (4) Myocardial infarction, moderate to severe congestive heart failure (New York Heart Association Class III or IV), new ischemic heart disease, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack within the 12 weeks prior to Screening, or if, at the time of Screening, in the opinion of the Investigator, participation in the Study would place the patient at an unacceptable risk or would pose an adverse effect on the outcome of the Study. Significant uncontrolled cardiovascular events that, in the opinion of the investigator at the time of screening, would place the patient at unacceptable risk or significantly interfere with the outcome of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankylosing spondylitis disease activity score (ASDAS-CRP); | — |
Secondary
| Measure | Time frame |
|---|---|
| Bath Ankylosing Spondylitis Index for Measuring Impairment (BASIMI);Ankylosing Spondylitis Attachment Score (MASES);The Bath Ankylosing Spondylitis Functional Index (BASFI);Ankylosing Spondylitis Quality of Life Score (ASQoL);C-reactive protein,CRP; | — |
Countries
China
Contacts
Wuhan NO.1 Hospital