Rheumatoid arthritis
Conditions
Interventions
Yunke group:Yunke 16.5mg (5.5mg*3 sets) / time for each course of treatment, 100ml saline intravenous drip after dissolution and dilution, once a day for 7 successive days
MTX group :Four oral tablets each time, and gradually increase to 6 tablets each time in four weeks or to the maximum tolerated dose of the patients
Combined treatment group :Yunke group+MTX group
Sponsors
Shanghai Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The diagnostic criteria that are proposed by American Rheumatism Association in 1987 shall be followed to detect the disease activity. Criteria for judging disease activity: any one who have any one symptom in a, b and c, d and e below can be diagnosed with active RA. (1) Joint swelling more than 4; (2) Joint tenderness more than 6; (3) Duration of morning stiffness longer than 45 minutes; (4) ESR (Westergren method) more than 28mm / h; (5) C-reactive protein (CRP) more than 1.5 times the upper limit of normal value. 2. Aged 18-65 years old; 3. Course of the disease shorter than 3 years; 4 Agreeing to take effective contraceptive measures during the trial; 5. Voluntary signing the informed consent; 6. Newly diagnosed patients, or the patients not having used MTX for the past 6 months, or the patients using MTX dose less than 10mg / w for 4w continuously; 7. If the subjects are taking other DMARDs during the screening, they should stop taking it at least four weeks before the trial; 8. If the subjects are taking biological agents or have ever participated in any relevant clinical trial during the screening, they shall stop the biological agents or clinical trials at least three months before this trial; 9. If the subjects are taking NSAIDs during the screening, the dose has been stable at least four weeks; 10. If the subjects are taking oral corticosteroids during the screening, the dose (equivalent to the dose of prednisone) must be stabled at below 10mg / days, for at least four weeks.
Exclusion criteria
Exclusion criteria: 1. The people who have abnormal liver functions (alanine or aspartate aminotransferase more than 2 times upper limit of normal value); or the people who have abnormal renal functions (serum creatinine level more than upper limit of normal value); WBC <4*10^9/L or PLT less than 100*10^9/L or the patients of hyperthyroidism, diabetes and other endocrine diseases; 2. Pregnant and lactant women; 3. Patients who prove MTX treatment is invalid (MTX more than at least 15mg / w, which is used for 3 consecutive months but ACR20 cannot be reached) or the ones with serious adverse reactions; 4. Patients who have received intra-articular corticosteroid treatment in the past 4 weeks; 5. Patients who have used technetium "99Tc" methylene diphosphonate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine blood test;Routine urine test;Liver and renal function;Erythrocyte sedimentation rate;C-reactive protein (CRP);Rheumatoid factor (RF); | — |
Countries
China
Contacts
Public ContactChunde Bao
Outcome results
None listed