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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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30 April 2019 |
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Main ID: |
ChiCTR1900022696 |
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Date of registration:
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2019-04-22 |
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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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A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndrome
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Scientific title:
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A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndrome |
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Date of first enrolment:
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2019-06-01 |
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Target sample size:
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experimental group :60;control group:60; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=34816 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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4
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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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Xuan Wang
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Address:
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Lane 389, Xincun Road, Putuo District, Shanghai
200000
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Telephone:
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+86 13918745569 |
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Email:
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baroquewang@icloud.com |
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Affiliation:
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Shanghai Tongji Hospital |
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Name:
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Jianping Tang
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Address:
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Shanghai tongji hospital, lane 389, xincun road, putuo district, Shanghai
200000
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Telephone:
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+86 18964869005 |
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Email:
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tangjp6512@126.com |
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Affiliation:
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Shanghai tongji hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) it meets the international classification standard of sjogren's syndrome in 2002; (2) aged 18-70 years, male or female; (3) ESSDAI 4 points; (4) the patient signed the informed consent and obtained the approval from the hospital ethics committee; (5) involvement of the blood system or lungs or liver.
Exclusion criteria: (1) those who are in the remission stage of primary sjogren's syndrome; (2) patients with severe heart failure, respiratory failure, liver dysfunction and renal failure; (3) combined with systemic or local severe infection; (4) have a history of multiple drug allergies; (5) lactating pregnant women.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sjogren syndrome
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Intervention(s)
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experimental group :Iguratimod 25mg bid po;control group:hydroxychloroquine 0.2-0.4g/d+prednison0.2-0.5mg/kg.d;
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Primary Outcome(s)
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ESSDAI grade;IgG?IgM?IgA of serum;C3?C4 of serum;
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Source(s) of Monetary Support
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scientific research funds
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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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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