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

NCT ID: NCT05424393

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-04
• Study Completion Date: 2025-12-31

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 disease activity will be observed for 2.5 years. During the maintenance period, through full communication between doctors and patients, YISAIPU 50 mg/wk or YISAIPU 25 mg/wk will be chosen as maintenance treatment. The clinical efficacy evaluation parameters include DAS28, HAQ-DI, modified Sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. Drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of YISAIPU due to adverse events. Exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of Interstitial Lung Disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

YISAIPU® ( An etanercept biosimilar)

Intervention Type: 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.

csDMARDs

Intervention Type: DRUG

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

Interventions

YISAIPU® ( An etanercept biosimilar)

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.

Intervention Type: DRUG

csDMARDs

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

Intervention Type: DRUG

Other Intervention Names

a recombinant tumor necrosis factor receptor-Fc fusion protein; rhTNFR:Fc

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guixiu Shi, MD PHD

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Xiamen University

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guixiu Shi, MD PHD

Role: CONTACT

gshi@xmu.edu.cn

8613600932661

Yan Li, MD PHD

Role: CONTACT

liy010203@163.com

8615960263763

Facility Contacts

Yan Li, PHD/MD

Role: primary

liy010203@163.com

8615960263763

Other Identifiers

FJ_RA_RWS_2021

Identifier Type: -

Identifier Source: org_study_id