Clinical trial NCT05424393: Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: clincal remission; low disease activity
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA patients in routine clinical practice environments

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.

Eligibility 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.

Primary outcomes:
measure: clinical remission defined by DAS28
timeFrame: 48 weeks
Secondary outcomes:
measure: clinical remission rate of RA at weeks 24, 96 and 144
timeFrame: weeks 24, 96 and 144
measure: low disease activity rate of RA at weeks 24, 48, 96 and 144
timeFrame: weeks 24, 48, 96 and 144
measure: joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144
timeFrame: weeks 24, 48, 96 and 144
measure: improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144
timeFrame: weeks 24, 48, 96 and 144
measure: scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144
timeFrame: weeks 24, 48, 96 and 144
measure: rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144
timeFrame: weeks 24, 48, 96 and 144
measure: changes of carotid intima-media thickness at weeks 48 and 144
timeFrame: weeks 48 and 144
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Guixiu Shi, MD PHD
role: STUDY_DIRECTOR
References: