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International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus (Adherence-SLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01509989
First received: December 1, 2011
Last updated: July 5, 2016
Last verified: July 2016
  Purpose

The treatment of systemic lupus erythematosus (SLE) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. However, one of the main causes of treatment failure in SLE is the lack of treatment adherence since "drugs don't work in patients who don't take them." Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and investigators have demonstrated that patients who do not take HCQ for a long time have undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients with a SLEDAI ≥12.

Investigators will evaluate the importance of non-adherence to the treatment in a large population of SLE patients with active disease. This will be done with blood HCQ monitoring in a translational multicentric prospective study.


Condition
Systemic Lupus Erythematosus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Adherence to the treatment in the whole group. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 ] [ Designated as safety issue: No ]
    The end points are adherence of the treatment in the whole group(defined by very low blood HCQ concentration)


Secondary Outcome Measures:
  • Secondary outcome [ Time Frame: up to 3 weeks ] [ Designated as safety issue: No ]

    Adherence according to central nervous system, to pregnancy, to the severity of SLE, to the center and the country.

    Adherence in the group of patients fulfilling the eligibility criteria of studies on monoclonal antibodies, The relationship between patients questionnaires, physician evaluation of adherence and blood HCQ dosage Interest of MASRI and Morisky questionnaires in the prediction of non-adherence Factors associated with poor adherence

    The socio-economic aspect of blood HCQ concentration measurement Pharmacokinetics studies on HCQ, with comparison to another cohort



Biospecimen Retention:   Samples With DNA
blood

Enrollment: 307
Study Start Date: January 2013
Study Completion Date: March 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

This international multicentric prospective study is an observational study that will include consecutive SLE patients treated with HCQ and with SLE flare (defined by the SELENA-SLEDAI flare composite). The study will only require the sampling of 1 vial of whole blood for the dosage of HCQ (that would be centralized and performed in PITIE-SALPETRIERE Hospital at the completion of the study). The patients and the physicians will also have adherence self-questionnaires to complete, and the physicians will complete a patient data sheet.

The end points are adherence of the treatment in the whole group, and subgroups, adherence according to the severity of SLE, and the relationship between patient's questionnaires, physician evaluation of adherence and blood HCQ dosage.

If investigators confirm their previous data, this study might demonstrate that a significant proportion of patient candidates for treatment escalation are in fact nonadherent to the treatment. It might further demonstrate the interest of HCQ concentrations monitoring, both in "real life" and in therapeutic study in SLE as it may avoid unnecessary, expensive or even hazardous regimen escalation.

  Eligibility

Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Active Systemic Lupus Erythematosus (see eligibility criteria)
Criteria

Inclusion criteria :

  • History of meeting 4 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus including a positive test for antinuclear antibodies,
  • SLE flare defined by the SELENA-SLEDAI flare composite
  • Treatment with HCQ for at least 2 months with a daily dosage > or equal to 200 mg/day.

Exclusion criteria :

  • Patients who are not able to take their medications (notably patients with repeated vomiting and patients who are not allowed to take oral medications)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509989

Locations
France
Hopital Cochin
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nathalie Costedoat-Chalumeau, MD Service de Médecine Interne, Hopital Cochin, 27, rue du Faubourg St Jacques, 75014 Paris, France. Email : nathalie.costedoat@gmail.com
Principal Investigator: Michelle Petri, MD Dept of Rheumatology, 1830 Building, Suite 7500. Email: mpetri@jhmi.edu
Principal Investigator: Jill Buyon, MD 560 First avenue, TCH-407, New York-NY 10016. Email: jill.buyon@nyumc.org
Principal Investigator: Ann Clarke, MD Lupus Clinic, Montreal General Hospital, Room A6163, 1650 Cedar Ave, Montreal, Quebec, Canada, H3G 1A4. Email: ann.clarke@mcgill.ca
Principal Investigator: Frederic Houssiau, MD Rheumatology Unit, Internal Medicine Department, Cliniques universitaires Saint-Luc, Université catholique de Louvain,Bruxelles, Belgium. Email: Frederic.Houssiau@uclouvain.be
Principal Investigator: Guillermo Ruiz-Irastorza, MD Autoimmune Disease Research Unit, Internal Medicine Department,Hospital de Cruces, University of the Basque Country, Barakaldo, Spain. Email: r.irastorza@euskaltel.net
Principal Investigator: Ricard Cervera, MD Department of Autoimmune Diseases, Hospital Clínic, rcervera@clinic.ub.es Barcelona, Catalonia, Spain. Email: rcervera@clinic.ub.es
Principal Investigator: David Isenberg, MD Department Inflammation, UCL Division of Medicine, Room 331 The Windeyer Building, 46 Cleveland Street, London, England. Email: d.isenberg@ucl.ac.uk
Principal Investigator: Yehuda Shoenfeld, MD Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 52621, Israel. Email: shoenfel@post.tau.ac.il
Principal Investigator: Ronald F. van Vollenhoven, MD Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska University Hospital, D10:0, Department of Rheumatology, 17176 Stockholm, Sweden. Email: Ronald.van.Vollenhoven@ki.se
Principal Investigator: Eric Hachulla, MD Service de Médecine Interne, Hôpital Claude Huriez, 1, place Verdun, 59000 Lille. Email: ehachulla2@yahoo.fr
Principal Investigator: Jean-François Viallard, MD Service de Médecine Interne, Hôpital Haut Lévêque, Centre François Magendie, 1, avenue Magellan, 33604 Pessac Cedex. Email: jean-francois.viallard@chu-bordeaux.fr
Principal Investigator: Loïc Guillevin, MD Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14. Email: loic.guillevin@wanadoo.fr
Principal Investigator: Luc Mouthon, MD Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14. Email: luc.mouthon@cch.aphp.fr
Principal Investigator: Veronique Leguern, MD Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14.
Principal Investigator: Jean-Charles Piette, MD Service de Médecine Interne, Hopital Pitié-Salpêtrière, 47-83 Boulevard de l'hôpital, 75013 Paris, France. Email: jcpiette@free.fr
Principal Investigator: Lionel Galicier, MD Service Immuno Clinique
Principal Investigator: Anne Laure Fauchais, MD Service de Médecine interne, Hôpital Dupuytren, 2, avenue Martin Luther King 87042 Limoges cedex
Principal Investigator: Holy Harifidy Bezanahrv, MD Service de Médecine interne, Hôpital Dupuytren, 2, avenue Martin Luther King 87042 Limoges cedex
Principal Investigator: Christophe deligny, MD Service de Médecine interne (3C), CHU de Martinique, Hôpital Pierre-Zobda-Quitman, CS 90631-97261 Fort de France cedex
Principal Investigator: Sandra Navarra, MD University of Santo Tomas Hospital, España Boulevard, Sampaloc, Manila, Philippines
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01509989     History of Changes
Other Study ID Numbers: Record2012 
Study First Received: December 1, 2011
Last Updated: July 5, 2016
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Adherence
Compliance
Systemic Lupus Erythematosus
Hydroxychloroquine
Blood monitoring
Flares

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016