rheumatoid arthritis
Conditions
Interventions
Experimental group:Abatacept 125mg SC each week
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18 to 65 years; 2. The weight is not less than 40kg; 3. Patients who meet the RA classification diagnostic criteria introduced by ACR in 1987 or ACR\EULAR in 2010, and are clearly diagnosed with rheumatoid arthritis (RA); 4. RA patients with moderate or high disease activity (DAS 28 > 3.2) at screening; 5. For women of childbearing potential, the screening and baseline pregnancy test results must be negative; 6. The patient has received traditional synthetic disease-modifying antirheumatic drugs (csDMARDs) for >= 3 months and has used tsDMARDs or other bDMARDs, and the treatment effect is not good.
Exclusion criteria
Exclusion criteria: 1. In the previous treatment of rheumatoid arthritis, the use of immunosuppressive drugs (cyclophosphamide, cyclosporine, azathioprine, etc.), tripterygium wilfordii and other drugs that affect the evaluation, and the drug withdrawal is less than 4 weeks; 2. Have a history of allergy to the relevant test drug or known intolerance to abatacept; 3. Subjects have recently received live (attenuated) vaccines, or plan to use any live (attenuated) vaccines during the study; 4. The presence of unsuccessful infection control at baseline. Infected subjects who are receiving treatment can be enrolled, but they cannot be administered until the infection is successfully treated; ANA positive judgment is caused by infection; 5. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C antibody positive with HCV RNA polymerase chain reaction positive at screening; HIV serology positive at screening 6. Subjects at risk of tuberculosis: positive TB-SPOT or PPD test; current clinical, radiological or laboratory evidence of active or occult tuberculosis; history of active tuberculosis within the past 3 years, even after receiving treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects in the treatment group who met the improvement criteria on the Health Assessment Questionnaire at the end of the 24th week of treatment; | — |
Countries
China
Contacts
Public ContactZhu Xiaochun
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed