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

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.

Conditions

• Systemic Lupus Erythematosus

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Nathalie Costedoat-Chalumeau, MD · Service de Médecine Interne, Hopital Cochin, 27, rue du Faubourg St Jacques, 75014 Paris, France. Email : [email protected]

• Michelle Petri, MD · Dept of Rheumatology, 1830 Building, Suite 7500. Email: [email protected]

• Jill Buyon, MD · 560 First avenue, TCH-407, New York-NY 10016. Email: [email protected]

• Ann Clarke, MD · Lupus Clinic, Montreal General Hospital, Room A6163, 1650 Cedar Ave, Montreal, Quebec, Canada, H3G 1A4. Email: [email protected]

• Frederic Houssiau, MD · Rheumatology Unit, Internal Medicine Department, Cliniques universitaires Saint-Luc, Université catholique de Louvain,Bruxelles, Belgium. Email: [email protected]

• Guillermo Ruiz-Irastorza, MD · Autoimmune Disease Research Unit, Internal Medicine Department,Hospital de Cruces, University of the Basque Country, Barakaldo, Spain. Email: [email protected]

• Ricard Cervera, MD · Department of Autoimmune Diseases, Hospital Clínic, [email protected] Barcelona, Catalonia, Spain. Email: [email protected]

• David Isenberg, MD · Department Inflammation, UCL Division of Medicine, Room 331 The Windeyer Building, 46 Cleveland Street, London, England. Email: [email protected]

• Yehuda Shoenfeld, MD · Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 52621, Israel. Email: [email protected]

• 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: [email protected]

• Eric Hachulla, MD · Service de Médecine Interne, Hôpital Claude Huriez, 1, place Verdun, 59000 Lille. Email: [email protected]

• Jean-François Viallard, MD · Service de Médecine Interne, Hôpital Haut Lévêque, Centre François Magendie, 1, avenue Magellan, 33604 Pessac Cedex. Email: [email protected]

• Loïc Guillevin, MD · Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14. Email: [email protected]

• Luc Mouthon, MD · Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14. Email: [email protected]

• Veronique Leguern, MD · Service de Médecine Interne, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, 75679 PARIS Cedex 14.

• Jean-Charles Piette, MD · Service de Médecine Interne, Hopital Pitié-Salpêtrière, 47-83 Boulevard de l'hôpital, 75013 Paris, France. Email: [email protected]

• Lionel Galicier, MD · Service Immuno Clinique

• Anne Laure Fauchais, MD · Service de Médecine interne, Hôpital Dupuytren, 2, avenue Martin Luther King 87042 Limoges cedex

• Holy Harifidy Bezanahrv, MD · Service de Médecine interne, Hôpital Dupuytren, 2, avenue Martin Luther King 87042 Limoges cedex

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

• Sandra Navarra, MD · University of Santo Tomas Hospital, España Boulevard, Sampaloc, Manila, Philippines

Eligibility

Min Age

6 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2015-12-31

Completion

2016-03-31

Countries

• France

Study Locations