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

Systemic Lupus Erythematosus Clinical Trial

— SLE,pSS,JIA  

Official title:

The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397107
• Other study ID #: 20K013-001
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.

Methods: Patients were divided into two groups. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

1. age <18 years old

2. meet the diagnostic criteria of disease classification

3. HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.

Exclusion Criteria:

1. heart failure (cardiac function = grade III NYHA)

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.

Related Conditions & MeSH terms

• Collagen Diseases
• Lupus Erythematosus, Systemic
• Rheumatic Diseases
• Systemic Lupus Erythematosus

Intervention

Drug:
• IL-2
Patients were received low dose recombinant human Interleukin-2

Locations

Country	Name	City	State
China	Sirui Yang	Changchun	Changchun/Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View Citation

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. Epub 2005 Oct 16. Erratum in: Nat Immunol. 2006 Apr;7(4):427. — View Citation

Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453-79. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Immunologic Impact of IL-2 Treatment	Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.	1 month,3 month,6 month,1 year
Secondary	Immunological Responses	Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood	1 month,3 month,6 month,1 year
Secondary	Change from baseline in SELENA SLEDAI Score	Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points.	1 month,3 month,6 month,1 year
Secondary	Change from baseline in EULAR SS disease activity index	Low-activity (ESSDAI<5),moderate-activity (5=ESSDAI=13) ,high-activity (ESSDAI=14) levels.	1 month,3 month,6 month,1 year
Secondary	Incidence of adverse drug reactions	Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event,drug-induced liver and kidney damage.	up to 1 year