The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases

NCT04397107 | Completed

• 1 other identifier: 20K013-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with rheumatic diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis).

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Change in steroid dose and immunosuppressor dose at 1 year compared to control group

  The average daily doses of steroid and immunosuppressor per square meter was recorded

  1 year

Secondary Outcomes (5)

• The Immunologic Impact of IL-2 Treatment

  1 month,3 month,6 month,1 year

• Immunological Responses

  1 month,3 month,6 month,1 year

• Change from baseline in SELENA SLEDAI Score

  1 month,3 month,6 month,1 year

• Change from baseline in EULAR SS disease activity index

  1 month,3 month,6 month,1 year

• Incidence of adverse drug reactions

  up to 1 year

Study Arms (2)

Recombinant Human Interleukin-2

EXPERIMENTAL

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.

Drug: IL-2

Traditional therapy

NO INTERVENTION

Patients were treated with glucocorticoid and/or immunosuppressor.

Interventions

IL-2 DRUG

Patients were received low dose recombinant human Interleukin-2

Also known as: Recombinant Human Interleukin-2 for Injection

Recombinant Human Interleukin-2

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age \<18 years old
• meet the diagnostic criteria of disease classification
• HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.

You may not qualify if:

• heart failure (cardiac function ≥ grade III NYHA)
• liver insufficiency (upper limit of normal range of transaminase \> 2 times)
• renal insufficiency (creatinine clearance ≤30ml/min)
• acute or severe infections such as bacteremia and sepsis
• malignant tumor
• high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month;Rituximab, infliximab or other biological agents were used
• mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
• Inability to comply with IL-2 treatment regimen.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

Sirui Yang

Changchun, Changchun/Jilin, 130000, China

Location

Related Publications (4)

• 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.

  PMID: 30472651 BACKGROUND

• 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.

  PMID: 16227984 BACKGROUND

• Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453-79. doi: 10.1146/annurev.immunol.26.021607.090357.

  PMID: 18062768 BACKGROUND

• 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.

  PMID: 21488890 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Interleukin-2; aldesleukin; Injections

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sirui Yang, MD and PhD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group patients were treated with IL-2 and another group patients were treated with routine therapy.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 21, 2020
• Study Start: August 15, 2020
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)