NCT03715699UnknownNot Applicable
Leflunomide Treatment for IgG4-RD
Peking Union Medical College Hospital1 site in 1 country70 target enrollmentStarted: July 1, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Response of Leflunomide treatment for IgG4-RD
Study Overview
Brief Summary
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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):
- •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;
- •elevated serum IgG4 (>1.35 g/L);
- •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;
- •exclusion of other diseases.
Exclusion Criteria
- •Patients will not be included if meets any of the following criteria:
- •Patients who were diagnosed as other autoimmune diseases;
- •Patients who were diagnosed as malignant diseases;
- •Pregnant and lactating women；
- •Active infection: HIV, HCV, HBV, TB；
- •Serious organ function failure, expected life time less than 6 months.
- •Presenting with Mikulicz disease without other manifestations.
Arms & Interventions
Group 1
Experimental
Patients treated with single glucocorticoid
Intervention: Prednisone (Drug)
Group 1
Experimental
Patients treated with single glucocorticoid
Intervention: Prednisone and Leflunomide (Drug)
Group 2
Experimental
Patients treated with Leflunomide and glucocorticoid
Intervention: Prednisone (Drug)
Group 2
Experimental
Patients treated with Leflunomide and glucocorticoid
Intervention: Prednisone and Leflunomide (Drug)
Outcomes
Primary Outcomes
Response of Leflunomide treatment for IgG4-RD
Time Frame: 1 year
Complete response rate; Partial response rate; No response
Secondary Outcomes
- Relapse of Leflunomide treatment for IgG4-RD(1 year)
Investigators
Wen Zhang
Professor
Peking Union Medical College Hospital
Study Sites (1)
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