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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01509989

Acronym

Adherence-SLE

Enrollment

307

Registered

2012-01-13

Start date

2013-01-01

Completion date

2016-03-01

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Adherence, Compliance, Systemic Lupus Erythematosus, Hydroxychloroquine, Blood monitoring, Flares

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Adherence to the treatment in the whole group.	participants will be followed for the duration of hospital stay, an expected average of 1	The end points are adherence of the treatment in the whole group(defined by very low blood HCQ concentration)

Secondary

Measure	Time frame	Description
Secondary outcome	up to 3 weeks	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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNathalie Costedoat-Chalumeau, MD

Service de Médecine Interne, Hopital Cochin, 27, rue du Faubourg St Jacques, 75014 Paris, France. Email : nathalie.costedoat@gmail.com

PRINCIPAL_INVESTIGATORMichelle Petri, MD

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

PRINCIPAL_INVESTIGATORJill Buyon, MD

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

PRINCIPAL_INVESTIGATORAnn Clarke, MD

Lupus Clinic, Montreal General Hospital, Room A6163, 1650 Cedar Ave, Montreal, Quebec, Canada, H3G 1A4. Email: ann.clarke@mcgill.ca

PRINCIPAL_INVESTIGATORFrederic Houssiau, MD

Rheumatology Unit, Internal Medicine Department, Cliniques universitaires Saint-Luc, Université catholique de Louvain,Bruxelles, Belgium. Email: Frederic.Houssiau@uclouvain.be

PRINCIPAL_INVESTIGATORGuillermo 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_INVESTIGATORRicard Cervera, MD

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

PRINCIPAL_INVESTIGATORDavid 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_INVESTIGATORYehuda Shoenfeld, MD

Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 52621, Israel. Email: shoenfel@post.tau.ac.il

PRINCIPAL_INVESTIGATORRonald 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_INVESTIGATOREric Hachulla, MD

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

PRINCIPAL_INVESTIGATORJean-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_INVESTIGATORLoïc Guillevin, MD

Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14. Email: loic.guillevin@wanadoo.fr

PRINCIPAL_INVESTIGATORLuc 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_INVESTIGATORVeronique Leguern, MD

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

PRINCIPAL_INVESTIGATORJean-Charles Piette, MD

Service de Médecine Interne, Hopital Pitié-Salpêtrière, 47-83 Boulevard de l'hôpital, 75013 Paris, France. Email: jcpiette@free.fr

PRINCIPAL_INVESTIGATORLionel Galicier, MD

Service Immuno Clinique

PRINCIPAL_INVESTIGATORAnne Laure Fauchais, MD

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

PRINCIPAL_INVESTIGATORHoly Harifidy Bezanahrv, MD

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

PRINCIPAL_INVESTIGATORChristophe deligny, MD

Service de Médecine interne (3C), CHU de Martinique, Hôpital Pierre-Zobda-Quitman, CS 90631-97261 Fort de France cedex

PRINCIPAL_INVESTIGATORSandra Navarra, MD

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

Outcome results