Lupus and Observance (LUPOBS)
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|ClinicalTrials.gov Identifier: NCT03019926|
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : September 20, 2018
A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.
New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.
Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.
The study primary objective is to determine risk factors for non-observance
The secondary objectives are to:
- Measure the observance rate of patients with systemic lupus in Martinique.
- Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.
|Condition or disease||Intervention/treatment|
|Systemic Lupus, Skin Lupus||Biological: Hydroxychloroquine dosage|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Lupus and Observance|
|Actual Study Start Date :||January 19, 2017|
|Actual Primary Completion Date :||August 17, 2018|
|Estimated Study Completion Date :||February 2019|
- Biological: Hydroxychloroquine dosage
Blood sample from a 6 ml tube, performed in the common practice.
- The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ) [ Time Frame: Reflects the Plaquenil intake during the 40 previous days ]
The HCQ dosage is assayed on whole blood (6ml) by high-pressure liquid chromatography performance, reproducible and inexpensive method. Only one laboratory centralizes the sampling.
A dosage below 200 ng/ml or 0.2 mg/l defines a non-observing patient within the 40 days above.
- Patients considered as observing and non-observing will be compared according to the activity of the disease [ Time Frame: 40 days ]Activity of the disease : Systemic lupus considered as active for a SELENA-SLEDAI score ≥ 6
- Patients considered as observing and non-observing will be compared according to number of prescribed medication [ Time Frame: 40 days ]
- Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders [ Time Frame: 40 days ]Presence of anxiety and/or depressive disorders, according to the Hospital Anxiety And Depression Scale (HAD), a score > to 10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019926
|Contact: Katlyne POLOMAT, MD||0596552255 ext +firstname.lastname@example.org|
|CHU de Martinique||Recruiting|
|Fort-de-France, Martinique, France, 97200|
|Contact: Katlyne POLOMAT, MD 0596552255 ext +596 email@example.com|
|Principal Investigator:||Katlyne POLOMAT, MD||CHU of Martinique|