Long-term treatment with YISAIPU for rheumatoid arthritis patients in Fujian

Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China

This study is testing how well a new treatment called YISAIPU works for people with rheumatoid arthritis in Fujian over a long period of time to see if it helps them stay healthy and safe.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT05424393 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the long-term efficacy and safety of YISAIPU, an etanercept biosimilar, in patients with rheumatoid arthritis (RA) from Fujian Province. Patients who have achieved clinical remission or low disease activity after 6 months of induction therapy will be monitored for 2.5 years. The study will assess clinical outcomes using various evaluation parameters and will also explore the incidence of interstitial lung disease and changes in carotid intima-media thickness. The treatment regimen will involve either YISAIPU 50 mg/week or 25 mg/week based on patient and physician discussions.

Who should consider this trial

Good fit: Ideal candidates are rheumatoid arthritis patients from Fujian who have completed 6 months of induction therapy and achieved clinical remission or low disease activity.

Not a fit: Patients with contraindications to TNF inhibitors or those currently participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of rheumatoid arthritis with YISAIPU, potentially improving patient outcomes.

How similar studies have performed: While this study focuses on a specific biosimilar, similar observational studies have shown promising results in evaluating long-term treatment outcomes for rheumatoid arthritis.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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.

Where this trial is running

Xiamen, Fujian

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Guixiu Shi, MD PHD

Conditions Rheumatoid Arthritis; clincal remission; low disease activity