Systemic Lupus ErythematosusNCT04942314
Practice of Treat-to-target on Pediatric Systemic Lupus Erythematosus: a Two-center Retrospective Study
An observational study of Systemic Lupus Erythematosus, run by Jia Deng.
Trial summary
Treat to target (T2T) strategies have proved to be useful in several chronic disorders, including Rheumatoid Arthritis. In systemic lupus erythematosus (SLE), T2T strategy has been proposed in order to control disease activity, improve health-related quality of life, and reduce morbidity and mortality. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Jun 2023
- Phase
- Observational
- 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 18 years
- All sexes
- Child, Adult
Study population: Children with SLE were diagnosed in the Children's Hospital of Chongqing Medical University and the Children's Hospital of Nanjing Medical University from January 2012 to December 2019 that meet the SLICC classification criteria for systemic lupus erythematosus (2012)
Who may be able to join
- (1）Children with SLE diagnosed by the SLICC classification criteria for systemic lupus erythematosus (2012); (2) Since diagnosed of SLE to follow-up termination, inpatient and/or outpatient follow-up at the research centers shall be carried out at least twice a year, the interval of follow-up is ≤3-6 months, and the total follow-up time is ≥1 year; (3) All children or guardians signed an informed consent file before inclusion.
Who cannot join
- the treatment plan is unknown;
- Excluding deaths caused by other diseases
- follow-up was interrupted;
- Follow-up time is less than 1 year, or interval is more than 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Treat to target (T2T) strategies have proved to be useful in several chronic disorders, including Rheumatoid Arthritis. In systemic lupus erythematosus (SLE), T2T strategy has been proposed in order to control disease activity, improve health-related quality of life, and reduce morbidity and mortality. Remission would be the main target, but a low disease activity state (LDAS) could be an acceptable alternative. However, due to SLE protean manifestations, the operational definitions of both remission and LDAS are still in progress. This clinical trial would like to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.
Read the detailed description
This two-center study retrospectively analyzed the follow-up data of children with systemic lupus erythematosus (SLE) in our center (the Children's Hospital of Chongqing Medical University) and the Children's Hospital of Nanjing Medical University, grouping the patients into two observation groups-low disease activity status Group (LDAS group) and never reached low disease activity group (Never LDAS group). We would analyze the risk factors of SLE that patients cannot reach LDAS by comparing baseline data and treatment conditions of the two groups. Meanwhile, we would evaluate the SLE clinical indicators, SLE disease activity, organ damage, and disease remission state at the end of the follow-up of the LDAS group, in order to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- pediatric, SLE, treat to target
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Complete remission off therapy | 1. no clinical activity and serological activity 2. stop taking corticosteroid and immunosuppressive drugs 3. antimalarials allowed | |
| Complete remission on therapy | 1. no clinical activity and serological activity 2. corticosteroid≤5 mg/day and immunosuppressive drugs allowed 3. antimalarials allowed | |
| Clinical remission off therapy | 1. no clinical activity but serological activity allowed 2. stop taking corticosteroid and immunosuppressive drugs 3. antimalarials allowed | |
| Clinical remission on therapy | 1. no clinical activity but serological activity allowed 2. corticosteroid≤5 mg/day and immunosuppressive drugs allowed 3. antimalarials allowed | |
| Low disease activity state | (1) SLEDAI-2K ≤4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever), and no haemolytic anaemia or gastrointestinal active involvement; (2) no new lupus disease activity compared with the previous assessment; (3) a PGA ≤1; (4) a current predni- sone (or equivalent) dose ≤7.5mg/day; and (5) well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. | |
| Not in LDAS or Remission | At the end of follow-up, the disease state of SLE children was not in LDAS or any remissions defined above. | |
| Never in LDAS | During the follow-up, the disease state was never get LDAS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for LDAS in children's SLE
grouping the patients into two observation groups-low disease activity status Group (LDAS group) and never reached low disease activity group (Never LDAS group). By comparing baseline data and treatment conditions of the two groups, The research would analyze the risk factors of SLE that patients cannot reach LDAS including demographic features, clinical manifestation, serologically activity, therapy at baseline.
Measured: 2021.07-2023.06
Secondary outcomes (1)
assess the clinical value of T2T strategy in the treatment of children with SLE
At the end of follow up, the LDAS group would be grouped into 6 groups including complete remission off therapy, complete remission on therapy, clinical remission off therapy, clinical remission on therapy, LDAS and not in LDAS or remisson.we would evaluate the SLE clinical indicators, SLE disease activity, organ damage, and disease remission state at the end of the follow-up of the LDAS group, in order to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.
Measured: 2021.07-2023.06
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jia Deng
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Nanjing Medical University
- Responsible party
- Sponsor-investigator, Jia Deng, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942314
- Sponsor's protocol ID
- CHChongqingMU-2021.03.30
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ugarte-Gil MF, Burgos PI, Alarcon GS. Treat to target in systemic lupus erythematosus: a commentary. Clin Rheumatol. 2016 Aug;35(8):1903-1907. doi: 10.1007/s10067-016-3346-2. Epub 2016 Jul 12.
PubMed 27406378Yu XX, Deng J, Chen QX, Qiu SY, Jiang CH, Wu YQ, Yang Q, Zhang GF, Yang HP, Zhao F, Li Q, Zhang AH, Wang M. Long-term outcomes and predictive factors of achieving low disease activity status in childhood systemic lupus erythematosus: a Chinese bicentric retrospective registered study. Front Immunol. 2024 Jun 10;15:1369969. doi: 10.3389/fimmu.2024.1369969. eCollection 2024.
PubMed 38915395
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Treat-to-target on Pediatric Systemic Lupus Erythematosus: a Two-center Retrospective Study
- ClinicalTrials.gov ID
- NCT04942314
- Acronym / sponsor ID
- CHChongqingMU-2021.03.30
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- pediatric, SLE, treat to target
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jia DengUniversity, hospital or other
- Collaborators
- Children's Hospital of Nanjing Medical University
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 28 Jun 2021 (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.
Treat to target (T2T) strategies have proved to be useful in several chronic disorders, including Rheumatoid Arthritis. In systemic lupus erythematosus (SLE), T2T strategy has been proposed in order to control disease activity, improve health-related quality of life, and reduce morbidity and mortality. Remission would be the main target, but a low disease activity state (LDAS) could be an acceptable alternative. However, due to SLE protean manifestations, the operational definitions of both remission and LDAS are still in progress. This clinical trial would like to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.
Detailed description
This two-center study retrospectively analyzed the follow-up data of children with systemic lupus erythematosus (SLE) in our center (the Children's Hospital of Chongqing Medical University) and the Children's Hospital of Nanjing Medical University, grouping the patients into two observation groups-low disease activity status Group (LDAS group) and never reached low disease activity group (Never LDAS group). We would analyze the risk factors of SLE that patients cannot reach LDAS by comparing baseline data and treatment conditions of the two groups. Meanwhile, we would evaluate the SLE clinical indicators, SLE disease activity, organ damage, and disease remission state at the end of the follow-up of the LDAS group, in order to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Complete remission off therapy | – | –1. no clinical activity and serological activity 2. stop taking corticosteroid and immunosuppressive drugs 3. antimalarials allowed |
| Complete remission on therapy | – | –1. no clinical activity and serological activity 2. corticosteroid≤5 mg/day and immunosuppressive drugs allowed 3. antimalarials allowed |
| Clinical remission off therapy | – | –1. no clinical activity but serological activity allowed 2. stop taking corticosteroid and immunosuppressive drugs 3. antimalarials allowed |
| Clinical remission on therapy | – | –1. no clinical activity but serological activity allowed 2. corticosteroid≤5 mg/day and immunosuppressive drugs allowed 3. antimalarials allowed |
| Low disease activity state | – | –(1) SLEDAI-2K ≤4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever), and no haemolytic anaemia or gastrointestinal active involvement; (2) no new lupus disease activity compared with the previous assessment; (3) a PGA ≤1; (4) a current predni- sone (or equivalent) dose ≤7.5mg/day; and (5) well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. |
| Not in LDAS or Remission | – | –At the end of follow-up, the disease state of SLE children was not in LDAS or any remissions defined above. |
| Never in LDAS | – | –During the follow-up, the disease state was never get LDAS. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with SLE were diagnosed in the Children's Hospital of Chongqing Medical University and the Children's Hospital of Nanjing Medical University from January 2012 to December 2019 that meet the SLICC classification criteria for systemic lupus erythematosus (2012)
Key inclusion criteria (1 listed)
- (1）Children with SLE diagnosed by the SLICC classification criteria for systemic lupus erythematosus (2012); (2) Since diagnosed of SLE to follow-up termination, inpatient and/or outpatient follow-up at the research centers shall be carried out at least twice a year, the interval of follow-up is ≤3-6 months, and the total follow-up time is ≥1 year; (3) All children or guardians signed an informed consent file before inclusion.
Key exclusion criteria (4 listed)
- the treatment plan is unknown;
- Excluding deaths caused by other diseases
- follow-up was interrupted;
- Follow-up time is less than 1 year, or interval is more than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors for LDAS in children's SLE
Time frame: 2021.07-2023.06
grouping the patients into two observation groups-low disease activity status Group (LDAS group) and never reached low disease activity group (Never LDAS group). By comparing baseline data and treatment conditions of the two groups, The research would analyze the risk factors of SLE that patients cannot reach LDAS including demographic features, clinical manifestation, serologically activity, therapy at baseline.
1 secondary outcome
assess the clinical value of T2T strategy in the treatment of children with SLE
Time frame: 2021.07-2023.06
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 27406378Ugarte-Gil MF, Burgos PI, Alarcon GS. Treat to target in systemic lupus erythematosus: a commentary. Clin Rheumatol. 2016 Aug;35(8):1903-1907. doi: 10.1007/s10067-016-3346-2. Epub 2016 Jul 12.
- Derived from this study: PubMed 38915395Yu XX, Deng J, Chen QX, Qiu SY, Jiang CH, Wu YQ, Yang Q, Zhang GF, Yang HP, Zhao F, Li Q, Zhang AH, Wang M. Long-term outcomes and predictive factors of achieving low disease activity status in childhood systemic lupus erythematosus: a Chinese bicentric retrospective registered study. Front Immunol. 2024 Jun 10;15:1369969. doi: 10.3389/fimmu.2024.1369969. eCollection 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Jia Deng.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Deng, master degree (+8615730301848, veronica48@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for LDAS in children's SLE (time frame: 2021.07-2023.06). 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 NCT04942314, which also lists 2 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 28 Jun 2021.