Glucocorticoids in Patients With IgG4-RD

NCT01758393 | Unknown Phase 2 DMC

• 1 other identifier: PUMCH-GC-IgG4RD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

IgG4-related Disease

Keywords

IgG4-related disease; IgG4-RD

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Disease Response

  3 months

• Adverse Effect

  3 months

Study Arms (2)

Medium Dose

EXPERIMENTAL

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.

Drug: Prednisone

High Dose

EXPERIMENTAL

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.

Drug: Prednisone

Interventions

Prednisone DRUG

High Dose; Medium Dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• Previously or currently received glucocorticoid and(or) immunomodulator
• Pregnancy or lactating
• Concurrent severe and/or uncontrolled and/or unstable diseases
• Patient with malignancy

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Wen Zhang, MD

  Deptment of Rheumatology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Fengchun Zhang

  Deptment of Rheumatology, Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Hua Chen, MD

CONTACT

+86-10-69158797; chenhua@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 1, 2013

Record last verified: 2012-12

Locations

CN (1)