The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases
NCT ID: NCT04397107
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2020-08-15
2022-06-30
Brief Summary
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Detailed Description
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Methods: Patients were divided into two groups. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Recombinant Human Interleukin-2
Induced remission period,recombinant human IL-2(500,000 unit per square meter) infusions five days;Maintenance treatment period,recombinant human IL-2 infusions five days then once every two weeks for 6 months.
IL-2
Patients were received low dose recombinant human Interleukin-2
Traditional therapy
Patients were treated with glucocorticoid and/or immunosuppressor.
No interventions assigned to this group
Interventions
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IL-2
Patients were received low dose recombinant human Interleukin-2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. meet the diagnostic criteria of disease classification
3. HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.
Exclusion Criteria
2. liver insufficiency (upper limit of normal range of transaminase \> 2 times)
3. renal insufficiency (creatinine clearance ≤30ml/min)
4. acute or severe infections such as bacteremia and sepsis
5. malignant tumor
6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month;Rituximab, infliximab or other biological agents were used
7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
8. Inability to comply with IL-2 treatment regimen.
17 Years
ALL
Yes
Sponsors
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The First Hospital of Jilin University
OTHER
Responsible Party
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Principal Investigators
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Sirui Yang, MD and PhD
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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Sirui Yang
Changchun, Changchun/Jilin, China
Countries
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References
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Rosenzwajg M, Lorenzon R, Cacoub P, Pham HP, Pitoiset F, El Soufi K, RIbet C, Bernard C, Aractingi S, Banneville B, Beaugerie L, Berenbaum F, Champey J, Chazouilleres O, Corpechot C, Fautrel B, Mekinian A, Regnier E, Saadoun D, Salem JE, Sellam J, Seksik P, Daguenel-Nguyen A, Doppler V, Mariau J, Vicaut E, Klatzmann D. Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial. Ann Rheum Dis. 2019 Feb;78(2):209-217. doi: 10.1136/annrheumdis-2018-214229. Epub 2018 Nov 24.
Fontenot JD, Rasmussen JP, Gavin MA, Rudensky AY. A function for interleukin 2 in Foxp3-expressing regulatory T cells. Nat Immunol. 2005 Nov;6(11):1142-51. doi: 10.1038/ni1263. Epub 2005 Oct 16.
Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453-79. doi: 10.1146/annurev.immunol.26.021607.090357.
Cheng G, Yu A, Malek TR. T-cell tolerance and the multi-functional role of IL-2R signaling in T-regulatory cells. Immunol Rev. 2011 May;241(1):63-76. doi: 10.1111/j.1600-065X.2011.01004.x.
Other Identifiers
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20K013-001
Identifier Type: -
Identifier Source: org_study_id
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