A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease
Overview
- Phase
- Phase 2
- Intervention
- Prednisone
- Conditions
- IgG4-related Disease
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Complete Response
- Last Updated
- 13 years ago
Overview
Brief Summary
This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.
Investigators
Wen Zhang
Professor
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •Males and females
- •Age 18-70 years old with informed consent
- •Patients with IgG4-RD:
- •swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, 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);
- •exclusion of other diseases.
Exclusion Criteria
- •Previously or currently received glucocorticoid and(or) immunomodulator
- •Pregnancy or lactating
- •Concurrent severe and/or uncontrolled and/or unstable diseases
- •Patient with malignancy
Arms & Interventions
Medium Dose
Patients are treated with prednisone or equivlent at doseage of 0.5-0.6 mg/kg/d (max 40mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
Intervention: Prednisone
High Dose
Patients are treated with prednisone or equivlent at doseage of 0.8-1.0 mg/kg/d (max 60mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
Intervention: Prednisone
Outcomes
Primary Outcomes
Complete Response
Time Frame: 3 months
Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.
Secondary Outcomes
- Disease Response(3 months)
- Adverse Effect(3 months)