Rheumatoid arthritis
Conditions
Interventions
Experimental group:Tocilizumab Injection
Sponsors
The First People’s Hospital of Lianyungang
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Patient age>= 18 years old; 2.Diagnosed by a doctor with rheumatoid arthritis, meeting the diagnostic criteria for RA classification formulated by ACR/EULAR in 2010; 3.RA disease activity (DAS28>=2.6); 4.No prior treatment with tocilizumab; 5.Good compliance and follow-up;
Exclusion criteria
Exclusion criteria: 1.Live vaccine immunization within 4 weeks prior to screening; 2.A history of latent tuberculosis infection or malignancy,where the investigator judges that the risks of tocilizumab treatment outweigh the benefits; 3.Acute or chronic active infections,where the investigator judges that the risks of tocilizumab treatment outweigh the benefits; 4.Accompanied by other diffuse connective tissue diseases such as systemic lupus erythematosus, severe knee osteoarthritis and Sjogren's syndrome; 5.Severe hepatic and renal insufficiency; 6.Severe heart, brain and vascular lesions; 7.Pregnant or lactating women; 8.Treatment with any biologic agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to initiation of tocilizumab therapy; 9.Those who have mental disorders, a history of alcoholism, immunodeficiency, drug or other substance abuse; 10.Those who are allergic to the ingredients of this product; 11.Other conditions deemed by the investigator as unsuitable for inclusion in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of ACR 20 Responders; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dosage of glucocorticoids;The DAS28-ESR scores;HAQ-DI scores;The proportion of subjects achieving ACR50 and ACR70 criteria;RA-PRO scale scores;Rate of treatment discontinuation/switching post-tocilizumab; | — |
Countries
China
Contacts
Public ContactHuijie Liu
The First People’s Hospital of Lianyungang
Outcome results
None listed