Back to resultsStudy of Treatment Response on IgG4 Related Disease (IgG4RD)
Primary Purpose
Autoimmune Disease
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prednisone
Prednisone and Mycophenolate mofetil
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Disease focused on measuring IgG4 related disease, IgG4-RD, Response rate, Relapse
Eligibility Criteria
Inclusion Criteria:
- Males and females
- Aged 18 to 70 years old with informed consent
All patients must meet the following diagnostic criteria of IgG4RD (2011):
- swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, 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). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
- exclusion of other diseases.
Exclusion Criteria:
Patients will not be included if meets any of the following criteria:
- Patients who were diagnosed as other autoimmune diseases;
- Patients who were diagnosed as malignant diseases;
- Pregnant and lactating women；
- Active infection: HIV, HCV, HBV, TB；
- Serious organ function failure, expected life time less than 6 months.
- Presenting with Mikulicz disease without other manifestations.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prednisone
Prednisone and Mycophenolate mofetil
Arm Description
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months. Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months.
Outcomes
Primary Outcome Measures
Complete and partial response rate at 3, 6, 9 and 12 months.
Complete and partial response are defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies
Secondary Outcome Measures
Disease response at 3, 6, 9 and 12 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.
Number of participants with adverse effect
Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Full Information
NCT ID
NCT02458196
First Posted
April 15, 2015
Last Updated
January 23, 2017
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02458196
Brief Title
Study of Treatment Response on IgG4 Related Disease (IgG4RD)
Official Title
A Randomized Trial of Treatment in Patients With IgG4-Related Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2018 (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 an open-label randomized controlled trial to compare the efficacy of Prednisone alone and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.
Detailed Description
Patients with IgG4-RD will be randomized in two therapeutic groups: Prednisone alone and combination therapy with Prednisone and Mycophenolate mofetil. These patients will be followed in 12 months. Treatment response and relapse will be recorded, as well as side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Disease
Keywords
IgG4 related disease, IgG4-RD, Response rate, Relapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
Experimental
Arm Description
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Arm Title
Prednisone and Mycophenolate mofetil
Arm Type
Experimental
Arm Description
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Pred, Prednisolone
Intervention Description
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 10mg/d to 12 months.
Intervention Type
Drug
Intervention Name(s)
Prednisone and Mycophenolate mofetil
Other Intervention Name(s)
MMF, Mycophenolate mofetil Dispersible Tablets
Intervention Description
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months.
Primary Outcome Measure Information:
Title
Complete and partial response rate at 3, 6, 9 and 12 months.
Description
Complete and partial response are defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Disease response at 3, 6, 9 and 12 months.
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
Up to 12 months
Title
Number of participants with adverse effect
Description
Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Time Frame
Up to 12 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
Aged 18 to 70 years old with informed consent
All patients must meet the following diagnostic criteria of IgG4RD (2011):
swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, 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). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
exclusion of other diseases.
Exclusion Criteria:
Patients will not be included if meets any of the following criteria:
Patients who were diagnosed as other autoimmune diseases;
Patients who were diagnosed as malignant diseases;
Pregnant and lactating women；
Active infection: HIV, HCV, HBV, TB；
Serious organ function failure, expected life time less than 6 months.
Presenting with Mikulicz disease without other manifestations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Zhang, Professor
Phone
861069158795
Email
zhangwen91@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yunyun Fei, Doctor
Phone
861069158797
Email
feiyunyun2013@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Zhang, Professor
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Zhang, Professor
Phone
861069155821
Email
zxpumch2003@sina.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
30124952
Citation
Yunyun F, Yu P, Panpan Z, Xia Z, Linyi P, Jiaxin Z, Li Z, Shangzhu Z, Jinjing L, Di W, Yamin L, Xiaowei L, Huadan X, Xuan Z, Xiaofeng Z, Fengchun Z, Yan Z, Wen Z. Efficacy and safety of low dose Mycophenolate mofetil treatment for immunoglobulin G4-related disease: a randomized clinical trial. Rheumatology (Oxford). 2019 Jan 1;58(1):52-60. doi: 10.1093/rheumatology/key227.
Results Reference
derived
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Study of Treatment Response on IgG4 Related Disease (IgG4RD)
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