NCT02857452

Brief Summary

The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life. The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients. This tool, validated in a British population, has never been validated in French.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

1.1 years

First QC Date

August 2, 2016

Last Update Submit

August 2, 2016

Conditions

Lupus

Outcome Measures

Primary Outcomes (1)

  • Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ)

    Evolution of answers between D0, D15, M3 and M6

Secondary Outcomes (1)

  • Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire

    Evolution of answers between D0, D15, M3 and M6

Study Arms (1)

Lupus

Other: SLA QuestionnaireOther: Lupus Qol Questionnaire

Interventions

SLA QuestionnaireOTHER
Lupus
Lupus Qol QuestionnaireOTHER
Lupus

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous

You may qualify if:

  • Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous.
  • Patients able to understand written and spoken French.
  • Patients who have been informed about the research

You may not qualify if:

  • Severe mental retardation.
  • Any impairment of ability to understand making self-evaluation impossible.
  • Age \< 18 years.
  • Age \> 75 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Study Design

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

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 5, 2016

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Last Updated

August 5, 2016

Record last verified: 2016-07

Locations

FR(1)