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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02458196
Date of registration: 15/04/2015
Prospective Registration: Yes
Primary sponsor: Peking Union Medical College Hospital
Public title: Study of Treatment Response on IgG4 Related Disease (IgG4RD)
Scientific title: A Randomized Trial of Treatment in Patients With IgG4-Related Disease
Date of first enrolment: April 2015
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02458196
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
China
Contacts
Name:     Xuan Zhang, Professor
Address: 
Telephone: 861069155821
Email: zxpumch2003@sina.com
Affiliation: 
Name:     Wen Zhang, Professor
Address: 
Telephone: 861069158795
Email: zhangwen91@sina.com
Affiliation: 
Name:     Wen Zhang, Professor
Address: 
Telephone:
Email:
Affiliation:  Peking Union Medical College Hospital
Key inclusion & exclusion 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):

1. 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;

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).
Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible
IgG4RD; 1)+3): probable IgG4RD;

4. exclusion of other diseases.

Exclusion Criteria:

- Patients will not be included if meets any of the following criteria:

1. Patients who were diagnosed as other autoimmune diseases;

2. Patients who were diagnosed as malignant diseases;

3. Pregnant and lactating women;

4. Active infection: HIV, HCV, HBV, TB;

5. Serious organ function failure, expected life time less than 6 months.

6. Presenting with Mikulicz disease without other manifestations.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Autoimmune Disease
Intervention(s)
Drug: Prednisone
Drug: Prednisone and Mycophenolate mofetil
Primary Outcome(s)
Complete and partial response rate at 3, 6, 9 and 12 months. [Time Frame: Up to 12 months]
Secondary Outcome(s)
Disease response at 3, 6, 9 and 12 months. [Time Frame: Up to 12 months]
Number of participants with adverse effect [Time Frame: Up to 12 months]
Secondary ID(s)
IgG4-02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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