Glucocorticoids in Patients With IgG4-RD

IgG4-related Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01758393
• Other study ID #: PUMCH-GC-IgG4RD
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: December 24, 2012
• Last updated: December 24, 2012
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2012
• Source: Peking Union Medical College Hospital
• Contact: Hua Chen, MD
• Phone: +86-10-69158797
• Email: chenhua[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• IgG4-related Disease

Intervention

Drug:
• Prednisone

Locations

Country	Name	City	State
China	Deptment of Rheumatology, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months
Secondary	Adverse Effect	Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.	3 months