Back to resultsLeflunomide Treatment for IgG4-RD
Primary Purpose
Autoimmune Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisone
Prednisone and Leflunomide
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Disease
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
- Yunyun FeiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Patients treated with single glucocorticoid
Patients treated with Leflunomide and glucocorticoid
Outcomes
Primary Outcome Measures
Response of Leflunomide treatment for IgG4-RD
Complete response rate; Partial response rate; No response
Secondary Outcome Measures
Relapse of Leflunomide treatment for IgG4-RD
Clinical relapse; Serological relapse
Full Information
NCT ID
NCT03715699
First Posted
September 25, 2018
Last Updated
October 21, 2018
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03715699
Brief Title
Leflunomide Treatment for IgG4-RD
Official Title
Leflunomide Treatment for IgG4-RD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patients treated with single glucocorticoid
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Patients treated with Leflunomide and glucocorticoid
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.
Intervention Type
Drug
Intervention Name(s)
Prednisone and Leflunomide
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.
Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.
Primary Outcome Measure Information:
Title
Response of Leflunomide treatment for IgG4-RD
Description
Complete response rate; Partial response rate; No response
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Relapse of Leflunomide treatment for IgG4-RD
Description
Clinical relapse; Serological relapse
Time Frame
1 year
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
Yunyun FEI
Phone
+8613681125226
Email
feiyunyun2013@hotmail.com
Facility Information:
Facility Name
Yunyun Fei
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunyun Fei
Phone
+8613681125226
Email
feiyunyun2013@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Leflunomide Treatment for IgG4-RD
We'll reach out to this number within 24 hrs