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Real-World Application Demonstration of Recombinant Human Tumor Necrosis Factor Receptor–Fc Fusion Protein Injection in Patients with Inflammatory Arthritis

Real-World Application Demonstration of Recombinant Human Tumor Necrosis Factor Receptor–Fc Fusion Protein Injection in Patients with Inflammatory Arthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115463
Enrollment
Unknown
Registered
2025-12-26
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Inflammatory arthritis, including rheumatoid arthritis and ankylosing spondylitis

Interventions

Recombinant Human Tumor Necrosis Factor Receptor–Fc Fusion Protein Injection Exposure group:NA

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Obtain a prescription for recombinant human type II tumor necrosis factor receptor antibody fusion protein injection; 2. Aged 18 years or older; 3. Fulfilling the diagnostic criteria for rheumatoid arthritis as defined by the American College of Rheumatology and the European Alliance of Associations for Rheumatology, or for ankylosing spondylitis as defined by the 1984 revised New York criteria of the American College of Rheumatology, and providing consent to participate in this study;

Exclusion criteria

Exclusion criteria: 1. Concurrent participation in any other interventional drug trial; 2. Life expectancy less than six months; 3. Any other condition that the investigator deems incompatible with study participation.

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving clinical remission or low disease activity;

Secondary

MeasureTime frame
12-month drug retention rate;Bath Ankylosing Spondylitis Functional Index;rate of adverse events leading to discontinuation;Health Assessment Questionnaire Disability Index;rate of SAEs;Rate of AEs;

Countries

China

Contacts

Public ContactHouwen Lin

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

franklin67@126.com+86 21 58752345

Outcome results

None listed

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