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CompletedNCT02364908ESSTIMUpdated Oct 17, 2018

Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus

An interventional study of therapeutic education in Systemic Lupus Erythematosus, sponsored by University Hospital, Lille. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

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Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • systemic lupus erythematosus
  • antimalarials
  • therapeutic education
  • Coping questionnaire
  • MASRI questionnaire
  • morisky medication adherence scale
  • lupus Quality Of Life
  • internal medicine
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In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 158 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
158 participants (actual)

Study arms

  • Other
    Patients with Systemic Lupus

    Other: therapeutic education

Interventions

  • Othertherapeutic education

    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.

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What researchers measure

Primary outcomes

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

    Time frame: baseline, at 12 months

Secondary outcomes

  1. hydroxychloroquinémie

    Monitoring of blood levels of hydroxychloroquinémie

    Time frame: between 6 months at 12 months

  2. number of non- adherent patients

    Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;

    Time frame: at 12 months

  3. quality of life scale Coping

    scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item

    Time frame: baseline, at 12 months

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Study locations

7 sites
  • CH Hôpital Duchenne
    Boulogne sur Mer, 62321, France
  • CH Douai
    Douai, 59507, France
  • CH Dunkerque
    Dunkerque, 59385, France
  • CH du Dr Schaffner
    Lens, 62307, France
  • CHRU, Hôpital Huriez
    Lille, France
  • Victor Provo Hospital
    Roubaix, 59056, France
  • Valenciennes hospital
    Valenciennes, 59322, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02364908
Lead sponsor
University Hospital, Lille
Collaborators
Région Nord-Pas de Calais, France
Responsible party
Sponsor
First posted
Feb 18, 2015
Start date
Dec 2014
Primary completion
Nov 30, 2016
Completion
Dec 2016
Last update
Oct 17, 2018

Study contacts

Eric Hachulla, MD, PhD
study chair · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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