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Research on Standardized Diagnosis and Treatment of Spondyloarthritis and Validation of Active Monitoring of Artificial Intelligence Drugs

Research on Standardized Diagnosis and Treatment of Spondyloarthritis and Validation of Active Monitoring of Artificial Intelligence Drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105268
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing spondylitis

Interventions

Observation group:N/A

Sponsors

Hong Kong University-Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years old; 2. Comply with the New York standards revised in 1984: Clinical criteria: Low back pain persists for at least 3 months and can be relieved after activity (rather than rest). (2) The movement of the lumbar vertebrae is restricted in both vertical and horizontal planes; (3) The degree of chest expansion is less than that of normal people of the same age and gender. Diagnostic criteria: Possessing unilateral grade 3-4 or bilateral grade 2-4 X-ray sacroiliitis, along with at least one of the three clinical criteria. 3. Meet the classification criteria of Axial spondyloarthritis (ASAS) in 2009: Patients with low back pain for >= 3 months and an onset age of less than 45 years (regardless of whether there are peripheral clinical manifestations or not) meet one of the following criteria: (1) Imaging shows sacroiliitis and has >= 1 feature of spondyloarthritis; (2) HLA-B27 positive and having >= 2 characteristics of spondyloarthritis. The characteristics of spondyloarthritis include: 1) Inflammatory low back pain; 2) Arthritis 3) Tendon attachment point inflammation (heel); 4) Uveitis 5) Finger (toe) inflammation 6) Psoriasis 7) Crohn's disease/Ulcerative colitis 8) NSAID treatment is effective; 9) Have a family history of spondyloarthritis; 10) HLA-B27 positive; 11) Elevated CRP.

Exclusion criteria

Exclusion criteria: If you meet any of the following criteria, you will not be enrolled in this study: 1 It cannot be combined with the detection of drug concentration and anti-antibodies during the research period. 2 Due to contraindications, they cannot be treated in accordance with the guidelines in a standardized manner, such as patients in the active stage of tuberculosis; 3 Within the last three months or currently participating in clinical trials; 4 There are situations where other researchers judged that it was not suitable to be included in the group.

Design outcomes

Primary

MeasureTime frame
BASDAI;ASDAS;Adalimumab drug concentration;Adalimumab antibody level;The drug concentration of Secukinumab;Secukinumab antibody level;

Secondary

MeasureTime frame
Erythrocyte sedimentation rate;C-reactive protein;

Countries

China

Contacts

Public ContactJinxian Huang

Hong Kong University Shenzhen Hospital

huangjx@hku-szh.org+86 183 0755 5163

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026