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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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ChiCTR |
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Last refreshed on:
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14 January 2019 |
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Main ID: |
ChiCTR1800020382 |
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Date of registration:
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2018-12-27 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus
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Scientific title:
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Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus |
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Date of first enrolment:
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2019-01-01 |
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Target sample size:
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Group 1:14;Group 2:14;Group 3:14; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=34340 |
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Study type:
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Observational study |
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Study design:
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Cohort study
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Phase:
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Pilot study
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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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Xu Xiaoxi
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Address:
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37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China
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Telephone:
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+86 17716469806 |
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Email:
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410127242@qq.com |
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Affiliation:
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West China hospital, Sichuan University |
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Name:
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Li Wei
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Address:
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37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China
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Telephone:
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+86 18980601695 |
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Email:
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724564806@qq.com |
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Affiliation:
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West China hospital, Sichuan University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients who meet the diagnostic criteria for pemphigus, especially those with long-term oral administration of corticosteriods or immunosuppressive agents;
Clinical manifestations:
(1) multiple looseness on the skin, easy to rupture bullae;
(2) refractory erosion surface secondary to blisters, scales or scars;
(3) non-infectious blisters or erosions in the mucosal area (including the oral mucosa);
(4) Nikolsky sign positive:
1) Histopathology: acanthosis; blister formation between epidermal cells;
2) Immunodiagnostic indicators: normal skin direct immunofluorescence (DIF) around the lesion area or lesions indicates IgG and/or complement deposition between epidermal cells; indirect immunofluorescence (IIF) detects anti-cell interphase in serum Anti-Dsg antibodies were detected in the serum by antibodies or ELISA.
2. Aged 18 to 80 years old;
3. Informed consent has been signed;
4. Women of childbearing age who have no birth plan.
Exclusion criteria: (1) Pregnant or lactating women;
(2) Women of childbearing age who have a birth plan;
(3) Those who are allergic to the drug;
(4) Patients with active hepatitis virus replication;
(5) HIV-positive patients; patients with potential tuberculosis infection;
(6) Combined with other diseases such as tumors, obvious systemic infections, arrhythmia, angina pectoris, cardiac insufficiency, etc.
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pemphigus
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Intervention(s)
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Group 1:Rituximab 500mg single infusion combined with routinedose of corticosteriods therapy;Group 2:Rituximab 100mg single infusion combined with routinedose of corticosteriods therapy;Group 3:Oral or intravenous infusion of routinedose of corticosteriods (prednisone or methylprednisolone);
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Primary Outcome(s)
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Partial remission rate;Complete remission rate;
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Secondary Outcome(s)
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Desmosin antibody 1;Desmosin antibody 3;B cell count;Pemphigus Disease Area Index;
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Source(s) of Monetary Support
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the Scientific Research Staring Foundation for the Returned Overseas Chinese Scholars,Ministry of China
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Ethics review
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Status: Approved
Approval date: 08/04/2018
Contact:
+86 28 85422654
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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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