Rheumatoid arthritis
Conditions
Interventions
Experimental group:Anbainuo plus methotrexate
Control group:Methotrexate, salazopyridine, leflumide, hydroxychloroquine
Sponsors
The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) RA was diagnosed with the the RA classification by the American rheumatoid association in 1987, or as defined by ACR and EULAR in 2010; (2) Aged 18-70 years; (3) Duration of disease longer than 3 months; (4) Moderate and severe disease activity (DAS28>=3.2), and CRP was increased by >15mg/L or ESR was elevated (female >30mm/h, male >20mm/h). DAS28 score was calculated by 4 parameters, in which CRP was used as acute phase reactant. (5) Oral NSAIDs is allowed (the maximum recommended dose is available), but the dose should be stable within 2 weeks prior to study. Oral administration of glucocorticoids (=4 weeks before inclusion; (6) The number of swelling or tenderness joints was greater than 3, in both hands (PIP/MCP), double wrists, double feet (PIP/MTP), and double ankle wrist joints (one for unilateral wrist and one for unilateral ankle); (7) Biological agent was not allowed within 3 months prior to study.
Exclusion criteria
Exclusion criteria: (1) Patients who are allergic to etanercept (Anbainuo) or its ingredients (see its instructions for details); (2) Patients who have had or are currently suffering from inflammatory arthritis besides RA, including gout, reactive arthritis, psoriatic arthritis, sero-negative spondylopathy, and lyme disease; (3) Patients who was associated with other autoimmune diseases other than RA, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, tuberculosis, and polymyositis; (4) Patients who was concurrent with severe and uncontrolled diseases of the heart and lung system, liver and kidney dysfunction, and gastrointestinal system diseases; (5) Patients who was concurrent with active or recurrent bacterial, viral, fungal, mycobacterial or other infections, and with history of infections; (6) Traditional Chinese medicine or acupuncture is prohibited throughout the study; (7) Patients with current or history of active tuberculosis; Patients with suspected tuberculosis by X - ray or CT; A history of TB exposure within 3 months; PPD test is strongly positive while the chest radiograph is negative; Chest CT should be performed when necessary to exclude tuberculosis; (8) History of malignant tumor; (9) Patients with pregnancy demand within one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response;DAS28;Incremental cost effect ratio;Quality adjusts life years; | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR50/70 response;ACR/EULAR remission;sharp/van der heijde score;health assessment questionnaire;the MOS item short from health survey-12;Ultrasonic score;erythrocyte sedimentation rate;C-reactive protein;cost analysis;Cost Minimization Analysis;Cost-effectiveness analysis;cost-utility analysis;Cost benefit analysis; | — |
Countries
China
Contacts
Public ContactJingyang Li
The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU.
Outcome results
None listed