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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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19 November 2018 |
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Main ID: |
ChiCTR1800019308 |
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Date of registration:
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2018-11-04 |
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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 tolerability of multitarget therapy with NHMX for systemic lupus erythematosus
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Scientific title:
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Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus |
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Date of first enrolment:
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2018-11-12 |
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Target sample size:
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NHMX:75;control:75; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=32677 |
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Study type:
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Interventional study |
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Study design:
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Cohort study
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Phase:
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Other
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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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Erwei Sun
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Address:
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183 Zhongshan Avenue West, Tianhe District, Guangzhou, Guangdong, China
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Telephone:
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+86 18666276163 |
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Email:
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sunew@smu.edu.cn |
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Affiliation:
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Department of Rheumatology and Immunology, The Third Affiliated Hospital, Southern Medical University |
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Name:
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Erwei Sun
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Address:
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183 Zhongshan Avenue West, Tianhe District, Guangzhou, Guangdong, China
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Telephone:
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+86 18666276163 |
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Email:
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sunew@smu.edu.cn |
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Affiliation:
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Department of Rheumatology and Immunology, The Third Affiliated Hospital, Southern Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subjects with SLE meet the American College of Rheumatology (ACR) standard, 1997;
2. Subjects who have a screening SLEDAI-2K score >=5;
3. Aged 18 to 65 years;
4. Signed the informed consent.
Exclusion criteria: Significant allergies to anti-malarials, NSAIDs, corticosteroids, cyclophosphamides, methotrexates, ciclosporins; Sever chronic liver, kidney dysfunction; Women who are pregnant or breast feeding; Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease,hematological system diseases etc.); Combination with other autoimmune diseases; Exposure to biological agents 12 months prior to enrollment Exposure to Methotrexate Hydroxychloroquine 3 months prior to enrollment Participation in another study with investigational drug within 8 weeks preceding the present study; Patients with mental disorder; Patients with active hemorrhage and digestive tract ulcer; History of visual interference or cataract patients; Chronic infections: HIV-positive individuals (increased risk of severe infections); Patients suffering from active hepatitis B or C are ineligible; Patients suffering from active tuberculosis are ineligible; History of cancer.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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systemic lupus erythematosus
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Intervention(s)
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NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l);
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Primary Outcome(s)
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SLE responder index-4;
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Secondary Outcome(s)
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SLEDAI Score;
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Source(s) of Monetary Support
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Guangdong Project of Science and Technology
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Ethics review
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Status: Approved
Approval date: 08/04/2018
Contact:
Zheng Qin
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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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