Rheumatoid Arthritis
Conditions
Keywords
clincal remission; low disease activity
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.
Interventions
DRUGYISAIPU® ( 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.
DRUGcsDMARDs
csDMARDs include methotrexate, sulfasalazine, hydroxychloroquine and leflunomide The use of csDMARDs complies with clinical routine practice and treatment strategy of treat-to-target.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical remission defined by DAS28 | 48 weeks | Clinical efficacy: Clinical remission rate achieved at 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical remission rate of RA at weeks 24, 96 and 144 | weeks 24, 96 and 144 | clinical remission rate of RA at weeks 24, 96 and 144 |
| low disease activity rate of RA at weeks 24, 48, 96 and 144 | weeks 24, 48, 96 and 144 | low disease activity rate of RA at 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 | improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144 |
| joint function remission (HAQ ≤0.5) rate 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 |
| rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144 | weeks 24, 48, 96 and 144 | rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144 |
| changes of carotid intima-media thickness at weeks 48 and 144 | weeks 48 and 144 | changes of carotid intima-media thickness at weeks 48 and 144 |
| scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144 | weeks 24, 48, 96 and 144 | scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 ，144 |
Countries
China
Contacts
Primary ContactGuixiu Shi, MD PHD
Backup ContactYan Li, MD PHD
Outcome results
None listed