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A flare prediction model for the biologics dose reduction in axial spondyloarthritis

A flare prediction model for the biologics dose reduction in axial spondyloarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102090
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-05-12

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:None

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: a) Voluntarily participate in this clinical trial and sign the informed consent form in writing; b) Age>=18 years; c) meet the diagnostic criteria for ankylosing spondylitis (AS) in New York, as revised in 1984, or meet the classification criteria for axial spondyloarthritis in ASAS in 2009, and the symptoms persist for >=3 months, and the age of onset <45 years; d) Patients who have been treated with biologics/targeted small molecule agents (TNFi, IL-17Ai or JAKi) for at least 6 months and have achieved sustained remission; Sustained remission is defined as ASDAS-ID (ASDAS<1.3) at the visit prior to enrollment (3 months ago) and at the time of enrollment (±7 days), and ASDAS-LDA (ASDAS<2.1) should be achieved at these two visits.

Exclusion criteria

Exclusion criteria: a) Those who have participated in other drug observation in the past 3 months; b) Those who have used adrenal glucocorticoids intra-articular or intramuscular injection within the past 1 month; c) Combined application of prednisone 10mg qd or more; d) Patients with obvious hematologic diseases and abnormal laboratory tests (blood WBC =2×ULN,AST>=2×ULN,GFR<=40ml/min; f) History of malignancy, decompensated cardiac insufficiency or severe hypertension, epilepsy and other neurological disorders, latent tuberculosis or tuberculosis TSPOT positive without using prophylactic anti-tuberculosis therapy, which the investigator considers unsuitable for participation; g) Those who have a history of alcoholism within 2 years; h) Pregnant and lactating women; i) In the opinion of the investigator, the subject has a secondary non-inflammatory disease (such as osteoarthritis, fibromyalgia), and its symptoms interfere with the evaluation of the effect of the study drug on the subject's axial spondyloarthritis.

Design outcomes

Primary

MeasureTime frame
Recurrence rate at 12 months of biologics reduction;

Countries

China

Contacts

Public ContactLiu Xu

Peking University People's Hospital

liuxupkupku@163.com+86 186 0128 4563

Outcome results

None listed

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