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

June 15, 2022 updated by: The First Affiliated Hospital of Xiamen University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Guixiu Shi, MD PHD
  • Phone Number: 8613600932661
  • Email: gshi@xmu.edu.cn

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
clinical remission defined by DAS28
Time Frame: 48 weeks
Clinical efficacy: Clinical remission rate achieved at 48 weeks
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
clinical remission rate of RA at weeks 24, 96 and 144
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: weeks 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
Time Frame: weeks 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
Time Frame: weeks 48 and 144
changes of carotid intima-media thickness at weeks 48 and 144
weeks 48 and 144

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Xiamen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Guixiu Shi, MD PHD, The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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