Glucocorticoids in Patients With IgG4-RD

Phase 2

• Conditions: IgG4-related Disease
• Interventions: Drug: Prednisone

• Registration Number: NCT01758393
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-24
• Study First Submitted QC: 2012-12-24
• Last Update Submitted: 2012-12-24
• Study First Posted: 2013-01-01
• Last Update Posted: 2013-01-01
• Primary Completion: 2014-01
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium Dose	Prednisone	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.
High Dose	Prednisone	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Deptment of Rheumatology, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China