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

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

Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: YISAIPU® ( An etanercept biosimilar); Drug: csDMARDs

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Guixiu Shi, MD PHD; Phone Number: 8613600932661; Email: gshi@xmu.edu.cn
• Study Contact Backup: Name: Yan Li, MD PHD; Phone Number: 8615960263763; Email: liy010203@163.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Yan Li, PHD/MD; Phone Number: 8615960263763; Email: liy010203@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

RA patients in routine clinical practice environments

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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.; Other Names: a recombinant tumor necrosis factor receptor-Fc fusion protein; rhTNFR:Fc; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical remission defined by DAS28	Clinical efficacy: Clinical remission rate achieved at 48 weeks	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University
• Investigators: Study Director: Guixiu Shi, MD PHD, The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: clincal remission; low disease activity
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: FJ_RA_RWS_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: share the study protocol
• IPD Sharing Time Frame: until completed
• IPD Sharing Access Criteria: Scholars in rheumatism
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No