Glucocorticoids in Patients With IgG4-RD

A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758393

Enrollment

Registered

2013-01-01

Start date

2012-12-31

Completion date

2014-04-30

Last updated

2013-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related Disease

Keywords

IgG4-related disease, IgG4-RD

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.

Interventions

DRUGPrednisone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete Response	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

Measure	Time frame	Description
Disease Response	3 months	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.
Adverse Effect	3 months	Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.

Countries

China

Contacts

Primary ContactHua Chen, MD

chenhua@pumch.cn+86-10-69158797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026