NCT01889654

Brief Summary

Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

June 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

June 25, 2013

Last Update Submit

September 7, 2017

Conditions

Systemic Lupus Erythematosus With or Without Clinical Activity

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    1 year

Study Arms (2)

patient

Other: Venous blood sampling

healthy volunteers

Other: Venous blood sampling

Interventions

Venous blood samplingOTHER
healthy volunteerspatient

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

lupus patient and healthy volunteers

You may qualify if:

  • SLE patient : diagnostic based on ACR criteria
  • SLE patient producing seric anti-nucleosome antibodies (ELISA)
  • SLEDAI-2K activity score : inferior to 5 for quiescent patients, superior to 8 since at least 2 months for active patients

You may not qualify if:

  • \-- Other autoimmune diseases than SLE- Induced lupus
  • Treatment with corticosteroids \>10mg/d (prednisone) for quiescent patients
  • Treatment with corticosteroids \>20mg/d (prednisone) for active patients
  • Oral immunosuppressive treatment during the last 6 months (methotrexate, azathioprine, ciclosporine, mycophénolate mofétil) for all patients, treatment during the last year with cyclophosphamide or monoclonal antibodies (rituximab, belimumab) for pour quiescent patients
  • Disease which can modify B and T lymphocyte functions: primary immune deficiencies, evolutive infections, chronic viral infection (VIH in particular), chemotherapy or neoplasm antecedent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas Rhin, 67091, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 28, 2013

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 11, 2017

Record last verified: 2017-01

Locations

FR(1)