LORMYFLong-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China
Data Collection
Collected from today forward - ProspectiveArthritis+6
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: March 4, 2022
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The First Affiliated Hospital of Xiamen University
Xiamen, ChinaOpen The First Affiliated Hospital of Xiamen University in Google Maps