NCT06551389

Brief Summary

Systemic lupus erythematosus is a complex systemicautoimmune disease that can affect most organs of the human body. Although they are many recommendations on the diagnosis and managment of SLE, diagnosis and therapeutic managment is still challenging. A pluridisciplinary consultation grouping rheumatologist, nephrologist, dermatologist, gynecologist, internist and immunologists has been set up in 2009 at the university hospital of Brest. The investigators would like to identify in a longitudinal cohort the occurrence of the different clinico-biological and immunological patterns of systemic lupus erythematosus patients during our multidisciplinary consultation. It is now crucial to organize a standardized data collection of these patients in order to evaluate our pratices, to be able to study the epidemiology of SLE in our city, and to promote this initiative at national and international level.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Oct 2020Apr 2035

First Submitted

Initial submission to the registry

June 20, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2035

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

14.5 years

First QC Date

June 20, 2019

Last Update Submit

June 24, 2026

Conditions

Keywords

autoimmune diseasesjoint diseasescutaneous systemic diseasesmusculoskeletal diseasesarthritisrheumatoidrheumatic diseasesconnectivite tissue diseasesimmune system diseases

Outcome Measures

Primary Outcomes (3)

  • Cohort data

    Prevalence and incidence of the clinico-biological and immunological patterns in a longitudinal cohort present in the standardized collection book including evaluation of différents criteria aspects : SLICC criteria

    one year

  • Cohort data

    Prevalence and incidence of the clinico-biological and immunological patterns in a longitudinal cohort present in the standardized collection book including evaluation of différents criteria aspects : SLEDAI score

    one year

  • Cohort data

    Prevalence and incidence of the clinico-biological and immunological patterns in a longitudinal cohort present in the standardized collection book including evaluation of différents criteria aspects : SDI score

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of the systemic lupus erythematous's multidisciplinary consultation at Brest CHRU

You may qualify if:

  • Any patient over 18 years old of the multidisciplinary consultation

You may not qualify if:

  • Opposition of patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biosamples in routine

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAutoimmune DiseasesJoint DiseasesMusculoskeletal DiseasesArthritisRheumatic DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Sandrine JOUSSE-JOULIN, Rheumatologist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

August 13, 2024

Study Start

October 13, 2020

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2035

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations