Systemic Lupus ErythematosusAdherence-SLENCT01509989
International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 307 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Active Systemic Lupus Erythematosus (see eligibility criteria)
Who may be able to join
- 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.
Who cannot join
- Patients who are not able to take their medications (notably patients with repeated vomiting and patients who are not allowed to take oral medications)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Adherence, Compliance, Systemic Lupus Erythematosus, Hydroxychloroquine, Blood monitoring, Flares
- Medical subject headings
- Lupus Erythematosus, Systemic, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: participants will be followed for the duration of hospital stay, an expected average of 1
Secondary outcomes (1)
Secondary outcome
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
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Nathalie Costedoat-Chalumeau, MD, Principal investigator, Service de Médecine Interne, Hopital Cochin, 27, rue du Faubourg St Jacques, 75014 Paris, France. Email : nathalie.costedoat@gmail.comMichelle Petri, MD, Principal investigator, Dept of Rheumatology, 1830 Building, Suite 7500. Email: mpetri@jhmi.eduJill Buyon, MD, Principal investigator, 560 First avenue, TCH-407, New York-NY 10016. Email: jill.buyon@nyumc.orgAnn Clarke, MD, Principal investigator, Lupus Clinic, Montreal General Hospital, Room A6163, 1650 Cedar Ave, Montreal, Quebec, Canada, H3G 1A4. Email: ann.clarke@mcgill.caFrederic Houssiau, MD, Principal investigator, Rheumatology Unit, Internal Medicine Department, Cliniques universitaires Saint-Luc, Université catholique de Louvain,Bruxelles, Belgium. Email: Frederic.Houssiau@uclouvain.beGuillermo Ruiz-Irastorza, MD, Principal investigator, Autoimmune Disease Research Unit, Internal Medicine Department,Hospital de Cruces, University of the Basque Country, Barakaldo, Spain. Email: r.irastorza@euskaltel.netRicard Cervera, MD, Principal investigator, Department of Autoimmune Diseases, Hospital Clínic, rcervera@clinic.ub.es Barcelona, Catalonia, Spain. Email: rcervera@clinic.ub.esDavid Isenberg, MD, Principal investigator, Department Inflammation, UCL Division of Medicine, Room 331 The Windeyer Building, 46 Cleveland Street, London, England. Email: d.isenberg@ucl.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509989
- Sponsor's protocol ID
- Record2012
- Acronym
- Adherence-SLE
- Status last verified
- Jul 2016
- First submitted
- 1 Dec 2011
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30079582Costedoat-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.
PubMed 28925027
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01509989
- Acronym / sponsor ID
- Adherence-SLE / Record2012
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Adherence, Compliance, Systemic Lupus Erythematosus, Hydroxychloroquine, Blood monitoring, Flares
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Active Systemic Lupus Erythematosus (see eligibility criteria)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who are not able to take their medications (notably patients with repeated vomiting and patients who are not allowed to take oral medications)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
The end points are adherence of the treatment in the whole group(defined by very low blood HCQ concentration)
1 secondary outcome
Secondary outcome
Time frame: up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 30079582Costedoat-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.
- Derived from this study: PubMed 28925027Costedoat-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.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Costedoat-Chalumeau, MD principal investigator
Service de Médecine Interne, Hopital Cochin, 27, rue du Faubourg St Jacques, 75014 Paris, France. Email : nathalie.costedoat@gmail.com
Michelle Petri, MD principal investigator
Dept of Rheumatology, 1830 Building, Suite 7500. Email: mpetri@jhmi.edu
Jill Buyon, MD principal investigator
560 First avenue, TCH-407, New York-NY 10016. Email: jill.buyon@nyumc.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509989, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.