NCT02364908

Brief Summary

This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...). The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

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

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

February 10, 2015

Last Update Submit

October 12, 2018

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosusantimalarialstherapeutic educationCoping questionnaireMASRI questionnairemorisky medication adherence scalelupus Quality Of Lifeinternal medicine

Outcome Measures

Primary Outcomes (1)

  • measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.

    baseline, at 12 months

Secondary Outcomes (3)

  • hydroxychloroquinémie

    between 6 months at 12 months

  • number of non- adherent patients

    at 12 months

  • quality of life scale Coping

    baseline, at 12 months

Study Arms (1)

Patients with Systemic Lupus

OTHER
Other: therapeutic education

Interventions

therapeutic educationOTHER

This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.

Patients with Systemic Lupus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a systemic lupus with ACR criteria (at least 4 criterias)
  • patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

You may not qualify if:

  • patients who refuse to sign the informed consent
  • patients who are under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CH Hôpital Duchenne

Boulogne-sur-Mer, 62321, France

Location

CH Douai

Douai, 59507, France

Location

CH Dunkerque

Dunkirk, 59385, France

Location

CH du Dr Schaffner

Lens, 62307, France

Location

CHRU, Hôpital Huriez

Lille, France

Location

Victor Provo Hospital

Roubaix, 59056, France

Location

Valenciennes hospital

Valenciennes, 59322, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eric Hachulla, MD, PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

December 1, 2014

Primary Completion

November 30, 2016

Study Completion

December 1, 2016

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)