Rheumatoid Arthritis
Conditions
Interventions
Treatment:TGP capsules (TGP) + methotrexate (MTX) + leflunom
Control:methotrexate(MTX) + leflunomide (LEF)
Sponsors
Anhui Provincial Hospital Department of Rheumatism
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 65 years with rheumatoid arthritis, diagnosed according to the criteria ACR87, male or female; 2. Patients with moderate to severe active, DAS28 score> 3.2?; 3. Patients treated previously with no immunosuppressive agents or biological agents before the trial; or with a single drug (MTX or LEF) treatment over 12 weeks without obvious effect; 4. Normal liver function before the study (no more than upper limit of normal of central laboratory); 5. Good compliance to guarantee the course of observation.
Exclusion criteria
Exclusion criteria: 1. Patient with a history of serious heart, liver, lung, kidney and other vital organs and endocrine system disease; 2. Patient with serious blood disorders or blood WBC less than 3000/mm3, platelets below80,000/mm3, hemoglobin less than 8g/dL; 3. Patient with a history of alcohol abuse; 4. Patients with influenza, hepatitis B (including hepatitis B virus), hepatitis C etc.; 5. Pregnancy or breast-feeding women; 6. Patients have known for TGP (TGP) drug allergy; or MTX, LEF allergy; 7. Patients who need insulin to control diabetes; or with uncontrolled high blood pressure; 8. Patient with gastrointestinal diseases such as chronic diarrhea, gastrointestinal ulcers, etc.; 9. Patients with systemic vasculitis; 10. Women of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| alanine aminotransferase;aspartate aminotransferas; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine tests;ESR;CRP;swollen joint count;tender joint count;patient overall assessment; | — |
Countries
China
Contacts
Public ContactLIXIANGPEI
Outcome results
None listed