search
Back to results

The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (SLE，pSS，JIA)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IL-2
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

undefined - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sirui Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recombinant Human Interleukin-2

Traditional therapy

Arm Description

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.

Patients were treated with glucocorticoid and/or immunosuppressor.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Immunologic Impact of IL-2 Treatment
Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.
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
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.
Change from baseline in EULAR SS disease activity index
Low-activity (ESSDAI<5),moderate-activity (5≤ESSDAI≤13) ,high-activity (ESSDAI≥14) levels.
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.

Full Information

First Posted
May 6, 2020
Last Updated
August 16, 2022
Sponsor
The First Hospital of Jilin University
search

1. Study Identification

Unique Protocol Identification Number
NCT04397107
Brief Title
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
One group patients were treated with IL-2 and another group patients were treated with routine therapy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Human Interleukin-2
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional therapy
Arm Type
No Intervention
Arm Description
Patients were treated with glucocorticoid and/or immunosuppressor.
Intervention Type
Drug
Intervention Name(s)
IL-2
Other Intervention Name(s)
Recombinant Human Interleukin-2 for Injection
Intervention Description
Patients were received low dose recombinant human Interleukin-2
Primary Outcome Measure Information:
Title
Change in steroid dose and immunosuppressor dose at 1 year compared to control group
Description
The average daily doses of steroid and immunosuppressor per square meter was recorded
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Immunologic Impact of IL-2 Treatment
Description
Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.
Time Frame
1 month,3 month,6 month,1 year
Title
Immunological Responses
Description
Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood
Time Frame
1 month,3 month,6 month,1 year
Title
Change from baseline in SELENA SLEDAI Score
Description
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.
Time Frame
1 month,3 month,6 month,1 year
Title
Change from baseline in EULAR SS disease activity index
Description
Low-activity (ESSDAI<5),moderate-activity (5≤ESSDAI≤13) ,high-activity (ESSDAI≥14) levels.
Time Frame
1 month,3 month,6 month,1 year
Title
Incidence of adverse drug reactions
Description
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age <18 years old meet the diagnostic criteria of disease classification HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirui Yang, MD and PhD
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sirui Yang
City
Changchun
State/Province
Changchun/Jilin
ZIP/Postal Code
130000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30472651
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.
Results Reference
background
PubMed Identifier
16227984
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. doi: 10.1038/ni1263. Epub 2005 Oct 16. Erratum In: Nat Immunol. 2006 Apr;7(4):427.
Results Reference
background
PubMed Identifier
18062768
Citation
Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453-79. doi: 10.1146/annurev.immunol.26.021607.090357.
Results Reference
background
PubMed Identifier
21488890
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs