Glucocorticoids in Patients With IgG4-RD

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01758393
First received: December 24, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

December 24, 2012
December 24, 2012
December 2012
January 2014   (final data collection date for primary outcome measure)
Complete Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.
Same as current
No Changes Posted
  • Disease Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Same as current
Not Provided
Not Provided
 
Glucocorticoids in Patients With IgG4-RD
A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
IgG4-related Disease
Drug: Prednisone
  • Experimental: Medium Dose
    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.
    Intervention: Drug: Prednisone
  • Experimental: High Dose
    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.
    Intervention: Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Hua Chen, MD +86-10-69158797 chenhua@pumch.cn
China
 
NCT01758393
PUMCH-GC-IgG4RD
Yes
Wen Zhang, Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Principal Investigator: Wen Zhang, MD Deptment of Rheumatology, Peking Union Medical College Hospital
Study Chair: Fengchun Zhang Deptment of Rheumatology, Peking Union Medical College Hospital
Peking Union Medical College Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP