Status:
UNKNOWN
Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Brief Summary
Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years
Detailed Description
This is a multi-center, prospective, real-world observational study. Patients who have completed 6 months of induction therapy (YISAIPU 50mg / week ± csDMARDs) and achieved clinical remission or low d...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Meet the ACR revised RA classification criteria(2010);
- Disease duration is more than or equal to 6 weeks;
- DAS28-CRP\>2.6;
- Patient is eligible for TNF inhibitors treatment according to the judgment of the attending doctor in clinical practice;
- A written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure.
Exclusion
- Exclusion criteria:
- Patient has contraindication(s) to the use of fusion-protein type of TNF inhibitor;
- Patient is participating in other ongoing drug clinical trials;
- Patient whose LTBI screening result is positive, or had not received standard anti-TB treatment for TB history, is unwilling to take prophylactic treatment for TB;
- Patient with HBV infection and positive for HBV replication (not up to active replication) is not willing to receive anti-HBV treatment;
- Anti-HCV antibody is positive and HCV-RNA is positive, and patient is unwilling to start anti-HCV treatment;
- Other reasons the researchers think the patient is not eligible for participation in the study.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05424393
Start Date
March 4 2022
End Date
December 31 2025
Last Update
June 21 2022
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000