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

NCT04942314 | Unknown

• 1 other identifier: CHChongqingMU-2021.03.30
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Systemic Lupus Erythematosus

Keywords

pediatric; SLE; treat to target

Outcome Measures

Primary Outcomes (1)

• 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.

  2021.07-2023.06

Secondary Outcomes (1)

• assess the clinical value of T2T strategy in the treatment of children with SLE

  2021.07-2023.06

Study Arms (7)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jia Deng: lead
• Children's Hospital of Nanjing Medical University: collaborator

Related Publications (1)

• 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.

  PMID: 27406378 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jia Deng, master degree

CONTACT

+8615730301848; veronica48@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master of medical degree

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 28, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share