Back to resultsGlucocorticoids in Patients With IgG4-RD
Primary Purpose
IgG4-related Disease
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for IgG4-related Disease focused on measuring IgG4-related disease, IgG4-RD
Eligibility Criteria
Inclusion Criteria:
- 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);
- 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
Sites / Locations
- Deptment of Rheumatology, Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Medium Dose
High Dose
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Adverse Effect
Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Full Information
NCT ID
NCT01758393
First Posted
December 24, 2012
Last Updated
December 24, 2012
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01758393
Brief Title
Glucocorticoids in Patients With IgG4-RD
Official Title
A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4-related Disease
Keywords
IgG4-related disease, IgG4-RD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medium Dose
Arm Type
Experimental
Arm 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.
Arm Title
High Dose
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Primary Outcome Measure Information:
Title
Complete Response
Description
Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Disease Response
Description
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.
Time Frame
3 months
Title
Adverse Effect
Description
Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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);
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Chen, MD
Phone
+86-10-69158797
Email
chenhua@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD
Organizational Affiliation
Deptment of Rheumatology, Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fengchun Zhang
Organizational Affiliation
Deptment of Rheumatology, Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Deptment of Rheumatology, Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD
Phone
+86-10-69158795
Email
zhangwen91@sina.com
First Name & Middle Initial & Last Name & Degree
Hua Chen, MD
Phone
+86-10-69158797
Email
chenhua@pumch.cn
12. IPD Sharing Statement
Learn more about this trial
Glucocorticoids in Patients With IgG4-RD
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