An observational study in Rheumatoid Arthritis, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by The First Affiliated Hospital of Xiamen University · Observational
Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 500 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
RA patients in routine clinical practice environments
Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
Exclusion criteria:
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) · Drug: csDMARDs
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.
Also known as: a recombinant tumor necrosis factor receptor-Fc fusion protein, rhTNFR:Fc
csDMARDs include methotrexate, sulfasalazine, hydroxychloroquine and leflunomide The use of csDMARDs complies with clinical routine practice and treatment strategy of treat-to-target.
clinical remission defined by DAS28
Clinical efficacy: Clinical remission rate achieved at 48 weeks
Time frame: 48 weeks
clinical remission rate of RA at weeks 24, 96 and 144
clinical remission rate of RA at weeks 24, 96 and 144
Time frame: 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
Time frame: 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
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
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
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
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
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
changes of carotid intima-media thickness at weeks 48 and 144
changes of carotid intima-media thickness at weeks 48 and 144
Time frame: weeks 48 and 144
Plan to share: Yes — share the study protocol
Supporting information: Study protocol
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