rheumatoid arthritis
Conditions
Interventions
A:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d)
B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week)
Sponsors
The Second Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed patients with aged 18 to 65 years who meet the Aerican College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria; 2. DAS28 score > 3.2; 3. Hemoglobin >=85g/L, white blood cells>=4*10^9/L, neutrophil count>=1.5*10^9/L, platelet>=100*10^9/L 4. Aminotransferase <=1.5 folds of upper limit of normal, creatinine<=120 mol/L (<=1.4 mg/dl); 5. Patients with good compliance and can regularly return to visit.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to sirolimus, sirolimus derivative or any other ingredients, or have recently received steroids, disease modifying anti-rheumatic drugs, or biological agents are excluded. 2. Patients who have other arthritis or autoimmune diseases, active infection, severe hypertension or cardiopulmonary insufficiency, epilepsy or nervous disorder, history of malignant tumor are not included. 3. Female patients who are during pregnancy and lactation, or plan to be pregnant in one year are excluded. 4. Other cases who may not complete the study or will take risks also are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20;DAS28;HAQ; | — |
Secondary
| Measure | Time frame |
|---|---|
| immunologic function;CD4+ T cell subsets;Cytokines detection; | — |
Countries
China
Contacts
Public ContactXiaofeng Li
The Second Hospital of Shanxi Medical University
Outcome results
None listed