Practice of Treat-to-target on Pediatric Systemic Lupus Erythematosus: a Two-center Retrospective Study

June 19, 2021 updated by: Jia Deng

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.

Study Overview

Status

Not yet recruiting

Conditions

Systemic Lupus Erythematosus

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jia Deng, master degree
Phone Number: +8615730301848
Email: veronica48@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

(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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Complete remission off therapy no clinical activity and serological activity stop taking corticosteroid and immunosuppressive drugs antimalarials allowed
Complete remission on therapy no clinical activity and serological activity corticosteroid≤5 mg/day and immunosuppressive drugs allowed antimalarials allowed
Clinical remission off therapy no clinical activity but serological activity allowed stop taking corticosteroid and immunosuppressive drugs antimalarials allowed
Clinical remission on therapy no clinical activity but serological activity allowed corticosteroid≤5 mg/day and immunosuppressive drugs allowed 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2021.07-2023.06

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the clinical value of T2T strategy in the treatment of children with SLE Time Frame: 2021.07-2023.06	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.	2021.07-2023.06

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jia Deng

Collaborators

Children's Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 6, 2021

First Submitted That Met QC Criteria

June 19, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)