Takayasu's arteritis
Conditions
Interventions
Mycophenolate mofetil treatment group:Mycophenolate mofetil combined low-dosage glucocorticoids for treatment of Takayasu's arteritis
Mycophenolate mofetil combined with other immunosuppressive drugs treatment group:Mycophenolate mofetil combined with other immunosuppressive drugs and low-dosage glucocorticoids for treatment of Taka
Sponsors
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Patients have to fulfill the classification criteria of modified 1990 American College of Rheumatology (ACR) criteria 13; 2. Patients must be in active disease based on the National Institutes of Health (NIH) criteria 2, defined as new-onset or worsening in at least two of the following: (1) systemic features, such as fever, musculoskeletal involvement (excluded other causes); (2) manifestations of ischemia or inflammation in vessels, such as claudication, pulse deficit, bruits, vascular pain, asymmetric blood pressure in upper and/or lower limbs; (3) elevated ESR and/or CRP protein levels, excluding the existence of active infection; (4) typical angiographic features. 3. Patients aged older than 18 years-old but below 45 years-old; 4. Either male or female could be included; 5. Patients with signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) intolerant or fail to response to MMF in the past history of treatment; (2) thiopurine methyl transferase (TPMT) gene test shows mutations; (3) un-controlled diabetes, hypertension before entry; (4) active digestive tract bleeding 3 months before entry; (5) severe liver and kidney dysfunction, and damage defined as the alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level were above 3 upper limits of the normal range and the serum creatinine level was 1.5 times above the upper limits; (6) patients with active infection , including bacteria, virus, fungi and mycobacteria; (7) Patients who are allergic to MMF, MTX or AZA; (8) Patient who is pregnant or who is planning for pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with full and partial effectiveness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who could reach full or partial response by MMF alone;Percentage of patients who could reach full or partial response by MMF combined with either Methotrexate or Azathioprine;The adverse events of MMF treatment; | — |
Countries
China
Contacts
Public ContactXinping Tian
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital
Outcome results
None listed