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Clinical trialNCT01509989CompletedObservational

International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus

SponsorAssistance Publique - Hôpitaux de ParisEnrollment307Systemic Lupus Erythematosus
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • 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
  • Anne Laure Fauchais, 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
  • 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
  • Eric Hachulla, MD

    Service de Médecine Interne, Hôpital Claude Huriez, 1, place Verdun, 59000 Lille. Email: ehachulla2@yahoo.fr

    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
  • Holy Harifidy Bezanahrv, MD

    Service de Médecine interne, Hôpital Dupuytren, 2, avenue Martin Luther King 87042 Limoges cedex

    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
  • 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
  • Jill Buyon, MD

    560 First avenue, TCH-407, New York-NY 10016. Email: jill.buyon@nyumc.org

    Principal InvestigatorKOL profile →
  • Lionel Galicier, MD

    Service Immuno Clinique

    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
  • Michelle Petri, MD

    Dept of Rheumatology, 1830 Building, Suite 7500. Email: mpetri@jhmi.edu

    Principal InvestigatorKOL profile →
  • 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
  • Ricard Cervera, MD

    Department of Autoimmune Diseases, Hospital Clínic, rcervera@clinic.ub.es Barcelona, Catalonia, Spain. Email: rcervera@clinic.ub.es

    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
  • Sandra Navarra, MD

    University of Santo Tomas Hospital, España Boulevard, Sampaloc, Manila, Philippines

    Principal Investigator
  • Veronique Leguern, MD

    Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14.

    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

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

France
  • Hopital Cochin

    Paris, France

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2013
Primary completion
31 Dec 2015
Completion
31 Mar 2016
Last update posted
8 Apr 2026
Registered enrollment
307
Registry id
NCT01509989

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.