NCT01509989

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 8, 2026

Status Verified

July 1, 2016

Enrollment Period

2.9 years

First QC Date

December 1, 2011

Last Update Submit

April 2, 2026

Conditions

Systemic Lupus Erythematosus

Keywords

AdherenceComplianceSystemic Lupus ErythematosusHydroxychloroquineBlood monitoringFlares

Outcome Measures

Primary Outcomes (1)

  • Adherence to the treatment in the whole group.

    The end points are adherence of the treatment in the whole group(defined by very low blood HCQ concentration)

    participants will be followed for the duration of hospital stay, an expected average of 1

Secondary Outcomes (1)

  • Secondary outcome

    up to 3 weeks

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Active Systemic Lupus Erythematosus (see eligibility criteria)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are not able to take their medications (notably patients with repeated vomiting and patients who are not allowed to take oral medications)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75679, France

Location

Related Publications (2)

  • Costedoat-Chalumeau N, Houssiau F, Izmirly P, Guern VL, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Vollenhoven RV, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2019 Aug;106(2):374-382. doi: 10.1002/cpt.1194. Epub 2018 Sep 2.

    PMID: 30079582DERIVED

  • Costedoat-Chalumeau N, Houssiau F, Izmirly P, Le Guern V, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Van Vollenhoven R, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2018 Jun;103(6):1074-1082. doi: 10.1002/cpt.885. Epub 2017 Nov 9.

    PMID: 28925027DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Lupus Erythematosus, SystemicPatient Compliance

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2011

First Posted

January 13, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

April 8, 2026

Record last verified: 2016-07

Locations

FR(1)