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Trial record 8 of 191 for:    lupus | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02364908
Recruitment Status : Recruiting
First Posted : February 18, 2015
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Région Nord-Pas de Calais, France
Information provided by (Responsible Party):
University Hospital, Lille

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).


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Other: therapeutic education Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Patients with Systemic Lupus Other: therapeutic 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.




Primary Outcome Measures :
  1. measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment. [ Time Frame: baseline, at 12 months ]

Secondary Outcome Measures :
  1. hydroxychloroquinémie [ Time Frame: between 6 months at 12 months ]
    Monitoring of blood levels of hydroxychloroquinémie

  2. number of non- adherent patients [ Time Frame: at 12 months ]
    Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;

  3. quality of life [ Time Frame: baseline, at 12 months ]
    scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364908


Contacts
Contact: Eric Hachulla, MD, PhD ehachulla2@yahoo.fr
Contact: Sarahe Dehimat, CRA sarahe.dehimat@chru-lille.fr

Locations
France
CH Hôpital Duchenne Recruiting
Boulogne sur Mer, France, 62321
Contact: Pierre Bataille, MD    +3321998210    pierre.m.bataille@gmail.com   
CH Douai Not yet recruiting
Douai, France, 59507
Contact: Anne-Laure Buchdahl, MD    +33327947450    alduchange@yahoo.fr   
CH Dunkerque Not yet recruiting
Dunkerque, France, 59385
Contact: Raymond Azar, MD    +33328285661      
CH du Dr Schaffner Not yet recruiting
Lens, France, 62307
Contact: Marie-Hélène Balquet, MD    +33321691234    mhbalquet@ch-lens.fr   
CHRU, Hôpital Huriez Recruiting
Lille, France
Contact: Eric Hachulla, MD, PhD         
Principal Investigator: Eric Hachulla, Md, PhD         
Victor Provo Hospital Recruiting
Roubaix, France, 59056
Contact: Eric Auxenfants, MD    +33320993198    eric.auxenfants@ch-roubaix.fr   
Valenciennes hospital Recruiting
Valenciennes, France, 59322
Contact: Laurence VRIGNEAU, MD    +33327143089      
Contact: Thomas Quemeneur, MD    +33327143089      
Sponsors and Collaborators
University Hospital, Lille
Région Nord-Pas de Calais, France
Investigators
Study Chair: Eric Hachulla, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02364908     History of Changes
Other Study ID Numbers: 2013_65
2014-A00735-42 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
systemic lupus erythematosus
antimalarials
therapeutic education
Coping questionnaire
MASRI questionnaire
morisky medication adherence scale
lupus Quality Of Life
internal medicine

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents