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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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23 October 2023 |
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Main ID: |
NCT04077684 |
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Date of registration:
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01/09/2019 |
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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 Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial
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Scientific title:
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Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial |
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Date of first enrolment:
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September 10, 2019 |
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Target sample size:
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160 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04077684 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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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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Xia Zhang |
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Address:
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Telephone:
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8615201303563 |
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Email:
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haoxiamei@163.com |
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Affiliation:
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Name:
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Xia Zhang, MD |
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Address:
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Telephone:
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Email:
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haoxiamei@163.com |
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Affiliation:
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Name:
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Zhanguo Li |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking University Institute of Rheumatology and Immunology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Meet the 1997 revised classification criteria of the American College of Rheumatology
2. SLE disease activity index(SLEDAI) = 8
3. age:18 to 75 years, weight 45-80Kg
4. Patients had an inadequate response to standard treatment for = 3 months. The
background treatment included corticosteroids (=1.0 mg/kg), hydroxychloroquine,
cyclophosphamide , mycophenolate mofetil or other immunosuppressants.
5. Negative urine pregnancy test
6. Written informed consent form
Exclusion Criteria:
1. allergic to IL-2, corticosteroids, hydroxychloroquine, cyclophosphamide or
mycophenolate mofetil
2. active severe neuropsychiatric manifestations of SLE;
3. hepatic insufficiency (alanine aminotransferase or aspartate aminotransferase = 2
times of the upper limit of the normal range);
4. pregnancy or lactation in females.
5. Cancer or history of cancer cured for less than five years (except in situ carcinoma
of the cervix or Basocellular carcinoma);
6. Serious infection such as bacteremia, sepsis;history of chronic infection;
7. active infection (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency
virus or Mycobacterium tuberculosis);
8. history vision and visual field disorders, cataract;
9. severe comorbidities including heart failure (= grade III NYHA)
10. active peptic ulcers;
11. complicated with other autoimmune diseases;
12. History of administration of rituximab or other biologics within 6 months;
13. therapy with other immunosuppressors;
14. participate in other clinical trial within 4 weeks;
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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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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Drug: Interleukin-2
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Primary Outcome(s)
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the response measured by the SLE Responder Index-4 (SRI-4)
[Time Frame: week 12]
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Secondary ID(s)
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2018PHB041-01
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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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