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

Rheumatoid Arthritis Clinical Trial

— LORMYF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424393
• Other study ID #: FJ_RA_RWS_2021
• Status: Recruiting
• Start date: March 4, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2022
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Guixiu Shi, MD PHD
• Phone: 8613600932661
• Email: gshi[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• YISAIPU® ( An etanercept biosimilar)
YISAIPU®, an etanercept biosimilar produced by 3SBio Inc., is a TNF-a inhibitor targeting soluble TNF-a 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
csDMARDs include methotrexate, sulfasalazine, hydroxychloroquine and leflunomide The use of csDMARDs complies with clinical routine practice and treatment strategy of treat-to-target.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical remission defined by DAS28	Clinical efficacy: Clinical remission rate achieved at 48 weeks	48 weeks
Secondary	clinical remission rate of RA at weeks 24, 96 and 144	clinical remission rate of RA at weeks 24, 96 and 144	weeks 24, 96 and 144
Secondary	low disease activity rate of RA at weeks 24, 48, 96 and 144	low disease activity rate of RA at weeks 24, 48, 96 and 144	weeks 24, 48, 96 and 144
Secondary	joint function remission (HAQ =0.5) rate at 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
Secondary	improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 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
Secondary	scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144	scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 ,144	weeks 24, 48, 96 and 144
Secondary	rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144	rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144	weeks 24, 48, 96 and 144
Secondary	changes of carotid intima-media thickness at weeks 48 and 144	changes of carotid intima-media thickness at weeks 48 and 144	weeks 48 and 144