Autoimmune Disease
Conditions
Brief summary
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.
Interventions
DRUGPrednisone
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.
DRUGPrednisone and Leflunomide
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months. Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males and females * Aged 18 to 70 years old with informed consent * All patients must meet the following diagnostic criteria of IgG4RD (2011): 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2. elevated serum IgG4 (\>1.35 g/L); 3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD; 4. exclusion of other diseases.
Exclusion criteria
* Patients will not be included if meets any of the following criteria: 1. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Serious organ function failure, expected life time less than 6 months. 6. Presenting with Mikulicz disease without other manifestations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response of Leflunomide treatment for IgG4-RD | 1 year | Complete response rate; Partial response rate; No response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse of Leflunomide treatment for IgG4-RD | 1 year | Clinical relapse; Serological relapse |
Countries
China
Contacts
Primary ContactYunyun FEI
Outcome results
None listed