rheumatoid arthritis
Conditions
Interventions
group one:HCQ(200mg/d)+MTX
group two:HCQ(400mg/d)+MTX
group three:HCQ(200mg/d)+SASP+MTX
group four:SASP+MTX
Sponsors
Renji Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Using the diagnostic criteria proposed by the American Rheumatism Association in 1987, the diagnosis was confirmed and the condition was active during screening. Judgment criteria for disease activity: Anyone who meets any of the following items a, b, c, d, and e can be diagnosed as active RA. a.Joint swelling >= 4; b.Joint tenderness >= 6; c.The duration of morning stiffness >= 45 minutes; d.Erythrocyte sedimentation rate (Wei's method) >= 28mm/h; e.C-reactive protein (CRP) >= 1.5 times the upper limit of normal 2. Age 18-65 years old; 3. Course of disease <= 3 years; 4. Agree to use effective contraceptive measures during the trial period; 5. Sign the informed consent form voluntarily; 6. Patients who have not used MTX in the past, or patients who have used MTX dose <= 10mg/w and have been used continuously for <4w; patients who have not used HCQ before, or who have used HCQ dose <= 200mg/D and used continuously < 4w patients; patients who have not used SASP before, or patients who have used SASP dose <= 2g/D and continuous use < 4w; if the subject is taking other DMARDs (except for MTX, HCQ and SASP, including Chinese medicines and preparations), need to be stopped for at least four weeks before the experiment; 7. If the subject is using biological agents or has participated in relevant clinical trials during screening, they must be stopped for at least 3 months before the experiment; 8. If the subject is taking NSAIDs during screening, the dose has been stable for at least four weeks; 9. If the subject is taking corticosteroids during screening, the dose (equivalent to the dose of prednisone) must be stabilized at <= 10mg/day for at least four weeks.
Exclusion criteria
Exclusion criteria: 1. Patients with severe heart, liver, kidney and other important organs, blood, endocrine system diseases and medical history; 2. Pregnant women and lactating women; 3. MTX treatment is confirmed to be ineffective (MTX >= 15mg/w, ACR20 cannot be achieved after 3 months of continuous use) or severe adverse reactions; 4. Hydroxychloroquine sulfate treatment is confirmed to be ineffective (HCQ >= 200mg/d, ACR20 cannot be achieved after 3 months of continuous use) or severe adverse reactions; 5. SASP treatment confirmed to be ineffective (SASP >= 500mg/d, ACR20 cannot be achieved after 3 months of continuous use) or severe adverse reactions; 6. Those who have received corticosteroid therapy in the joint cavity within 4 weeks; 7. Using anti-tumor necrosis factor antagonist, IL-6 antagonist, anti-CD20 monoclonal antibody and other biological agents within 12 weeks before joining the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20;ACR50;ACR70;DAS28;scores of Sharp;Adverse reaction rate; | — |
Countries
china
Contacts
Public ContactDongyi He
Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed