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Patient-reported outcomes and treatment outcomes in patients with axial arthritis of the spine treated with adamuzumab versus conventional drugs

Patient-reported outcomes and treatment outcomes in patients with axial arthritis of the spine treated with adamuzumab versus conventional drugs

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053455
Enrollment
Unknown
Registered
2021-11-21
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

Axial arthritis of the spine

Interventions

Group 1:Adequate adamuzumab dose for 52 weeks
Group 2:Adequate dosage of adamuzumab for 12 weeks
Group 3:Use NSAIDs, csDMARDs or other oral medications

Sponsors

The Second Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. In line with the 2009 International Spondyloarthritis Association (ASAS) axSpA classification criteria; 3. Non-steroidal anti-inflammatory drugs alone or other local treatment drugs have poor control effect or intolerance.

Exclusion criteria

Exclusion criteria: 1. Received other biological agents and targeted drug therapy in the past; 2. Those who are in the period of systemic acute or chronic infection, or have a history of active tuberculosis in the past; 3. Malignant tumor; 4. Moderate to severe heart failure (New York Heart Association grade 3-4); 5. Pregnant women and lactating women; 6. Those who are allergic to adalimumab components.

Design outcomes

Primary

MeasureTime frame
blood routine examination;urine routine examination;C-reactive protein;Blood sedimentation;CT of sacroiliac joint;MRI of sacroiliac joint;

Secondary

MeasureTime frame
Changes in PROs at each follow-up point compared to baseline;Changes in disease activity at each follow-up point compared with baseline;

Countries

China

Contacts

Public ContactLi Meiling

The Second Affiliated Hospital of Guangxi Medical University

2189356143@qq.com+86 18260948598

Outcome results

None listed

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