Systemic Lupus ErythematosusSLE，pSS，JIANCT04397107
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases
A study testing IL-2 in people with Systemic Lupus Erythematosus, run by The First Hospital of Jilin University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- IL-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age <18 years old
- meet the diagnostic criteria of disease classification
- HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- IL-2
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2Drug
Also called Recombinant Human Interleukin-2 for Injection
Patients were received low dose recombinant human Interleukin-2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IL-2 |
| Traditional therapy | No intervention | Patients were treated with glucocorticoid and/or immunosuppressor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
The Immunologic Impact of IL-2 Treatment
Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.
Measured: 1 month,3 month,6 month,1 year
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
Measured: 1 month,3 month,6 month,1 year
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.
Measured: 1 month,3 month,6 month,1 year
Change from baseline in EULAR SS disease activity index
Low-activity (ESSDAI<5),moderate-activity (5≤ESSDAI≤13) ,high-activity (ESSDAI≥14) levels.
Measured: 1 month,3 month,6 month,1 year
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start15 Aug 2020
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- One group patients were treated with IL-2 and another group patients were treated with routine therapy.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirui Yang, MD and PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397107
- Sponsor's protocol ID
- 20K013-001
- Acronym
- SLE，pSS，JIA
- Status last verified
- Aug 2022
- First submitted
- 6 May 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30472651Fontenot 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.
PubMed 16227984Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453-79. doi: 10.1146/annurev.immunol.26.021607.090357.
PubMed 18062768Cheng 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.
PubMed 21488890
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04397107
- Acronym / sponsor ID
- SLE，pSS，JIA / 20K013-001
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group patients were treated with IL-2 and another group patients were treated with routine therapy.
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Interleukin-2 | Experimental | Drug: IL-2Induced 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. |
| Traditional therapy | No intervention | –Patients were treated with glucocorticoid and/or immunosuppressor. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age <18 years old
- meet the diagnostic criteria of disease classification
- HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-2Also: Recombinant Human Interleukin-2 for InjectionPatients were received low dose recombinant human Interleukin-2 | Drug | Recombinant Human Interleukin-2 |
Primary outcome
Change in steroid dose and immunosuppressor dose at 1 year compared to control group
Time frame: 1 year
The average daily doses of steroid and immunosuppressor per square meter was recorded
5 secondary outcomes
The Immunologic Impact of IL-2 Treatment
Time frame: 1 month,3 month,6 month,1 year
Immunological Responses
Time frame: 1 month,3 month,6 month,1 year
Change from baseline in SELENA SLEDAI Score
Time frame: 1 month,3 month,6 month,1 year
Change from baseline in EULAR SS disease activity index
Time frame: 1 month,3 month,6 month,1 year
Incidence of adverse drug reactions
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 30472651Rosenzwajg 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.
- Background: PubMed 16227984Fontenot 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.
- Background: PubMed 18062768Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453-79. doi: 10.1146/annurev.immunol.26.021607.090357.
- Background: PubMed 21488890Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirui Yang, MD and PhD principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IL-2 in people with Systemic Lupus Erythematosus, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in steroid dose and immunosuppressor dose at 1 year compared to control group (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.