Rheumatoid Arthritis
Conditions
Interventions
Treatment Group:Immunoadsorption therapy (once each on D3, D6, D9) + Qinxitong tablets (5 tablets/time, 2 times/day) + basic therapy
Control Group:Traditional triple DMARD combination therapy (methotrexate 15 mg/week + leflunomide 20 mg/day + hydroxychloroquine 0.2 g twice daily) + basic therapy
Sponsors
Xi'an Fifth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18-65 years, any gender Meeting the 2010 ACR/EULAR classification criteria for rheumatoid arthritis Meeting the definition of refractory RA: treatment with =2 conventional DMARDs (including methotrexate) at adequate doses for =3 months, with DAS28 score still >3.2 Positive serum RF and/or anti-CCP antibodies Signed informed consent
Exclusion criteria
Exclusion criteria: Concomitant other connective tissue diseases Severe cardiac, hepatic, or renal dysfunction (liver function >3 times upper limit of normal, creatinine >176.8µmol/L) Active infection or malignancy Pregnant or lactating women Allergy to study medications Participation in other clinical trials within 3 months Mental illness or cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR50 Response Rate;morning stiffness duration;DAS28 Score and Its Change Value;morning stiffness duration;Patient pain VAS score;HAQ-DI Functional Score;Laboratory indicators; | — |
Countries
China
Contacts
Public ContactZhang Wei
Xi'an Fifth Hospital
Outcome results
None listed