Glucocorticoids in Patients With IgG4-RD

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3; Phase 2

Conditions: IgG4-related Disease

Treatments: Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01758393

PUMCH-GC-IgG4RD

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Medium Dose

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

High Dose

Experimental group

Description:

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.

Treatment:

Drug: Prednisone