Glucocorticoids in Patients With IgG4-RD

Peking Union Medical College Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgG4-related Disease

Interventions

PrednisoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females * Age 18-70 years old with informed consent * Patients with IgG4-RD: 1. 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; 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); 4. 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

Locations (1)

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Complete Response

Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.

Time frame: 3 months

Secondary Outcomes

Disease Response

Disease Response is measured by IgG4-RD Responder Index(IgG4-RD RI) and defined as: * Improvement of \> 2 points in the IgG4-RD RI over baseline * No disease flares, as assessed by the IgG4-RD RI.

Time frame: 3 months

Adverse Effect

Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.

Time frame: 3 months

Central Contacts

Hua Chen, MD

CONTACT

+86-10-69158797 chenhua@pumch.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.