Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients

NCT05424393 | Unknown

• 1 other identifier: FJ_RA_RWS_2021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Keywords

clincal remission; low disease activity

Outcome Measures

Primary Outcomes (1)

• clinical remission defined by DAS28

  Clinical efficacy: Clinical remission rate achieved at 48 weeks

  48 weeks

Secondary Outcomes (7)

• clinical remission rate of RA at weeks 24, 96 and 144

  weeks 24, 96 and 144

• low disease activity rate of RA at weeks 24, 48, 96 and 144

  weeks 24, 48, 96 and 144

• joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144

  weeks 24, 48, 96 and 144

• improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144

  weeks 24, 48, 96 and 144

• scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144

  weeks 24, 48, 96 and 144

Study Arms (1)

RA Patients receiving routine treatment

During the induction phase, the dose of YISAIPU is 50mg/wk. Patients who achieved clinical remission or low activity after 24 weeks of induction treatment can enter the maintenance phase. Those who fail to succeed in induction treatment will not be followed up. During the maintenance phase, the dose of YISAIPU could be either 50mg/wk or 25mg/wk. Patients will be followed up regularly for 2.5 years.

Drug: YISAIPU® ( An etanercept biosimilar); Drug: csDMARDs

Interventions

YISAIPU® ( An etanercept biosimilar) DRUG

YISAIPU®, an etanercept biosimilar produced by 3SBio Inc., is a TNF-α inhibitor targeting soluble TNF-α to inhibit its interaction with cell-surface receptors. It has been widely used in clinical practice for 17 years in China. According to the prescription information, YISAIPU should be given as 25mg, biw, pc.

Also known as: a recombinant tumor necrosis factor receptor-Fc fusion protein, rhTNFR:Fc

RA Patients receiving routine treatment

csDMARDs DRUG

csDMARDs include methotrexate, sulfasalazine, hydroxychloroquine and leflunomide The use of csDMARDs complies with clinical routine practice and treatment strategy of treat-to-target.

RA Patients receiving routine treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RA patients in routine clinical practice environments

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

no need

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Guixiu Shi, MD PHD

  The First Affiliated Hospital of Xiamen University

  STUDY DIRECTOR

Central Study Contacts

Guixiu Shi, MD PHD

CONTACT

8613600932661; gshi@xmu.edu.cn

Yan Li, MD PHD

CONTACT

8615960263763; liy010203@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: March 4, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: until completed
• Access Criteria: Scholars in rheumatism

Locations

CN (1)