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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01758393 |
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Date of registration:
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24/12/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Glucocorticoids in Patients With IgG4-RD
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Scientific title:
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A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01758393 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Fengchun Zhang |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deptment of Rheumatology, Peking Union Medical College Hospital |
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Name:
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Wen Zhang, MD |
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Address:
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Telephone:
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+86-10-69158795 |
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Email:
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zhangwen91@sina.com |
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Affiliation:
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Name:
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Hua Chen, MD |
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Address:
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Telephone:
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+86-10-69158797 |
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Email:
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chenhua@pumch.cn |
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Affiliation:
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Name:
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Wen Zhang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deptment of Rheumatology, Peking Union Medical College Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgG4-related Disease
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Intervention(s)
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Drug: Prednisone
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Primary Outcome(s)
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Complete Response
[Time Frame: 3 months]
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Secondary Outcome(s)
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Adverse Effect
[Time Frame: 3 months]
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Disease Response
[Time Frame: 3 months]
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Secondary ID(s)
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PUMCH-GC-IgG4RD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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