Lupus and Observance (LUPOBS)

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus, Skin Lupus
• Intervention / Treatment: Biological: Hydroxychloroquine dosage

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Martinique
    • Fort-de-France, Martinique, France, 97200
      • CHU de Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will is proposed to anyone aged 18 years or older with a diagnosis of systemic lupus or skin lupus for at least 6 months, ans who has been prescribed with hydroxychloroquine (Plaquenil) for at least 6 months.

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Systemic lupus defined according to the diagnostic criteria of the American College of Rheumatology " 1997, diagnosed for at least 6 months; Or Skin Lupus
3. Consultation or hospitalization at the University Hospital of Martinique, in either services of Internal Medicine, Rheumatology or Dermatology.
4. Prescription of hydroxychloroquine (Plaquenil®) for at least 6 months
5. Affiliate or beneficiary of a social security scheme.
6. Patient not opposed to participate in the study

Exclusion Criteria:

1. Age <18 years or patient under guardianship
2. Patient not speaking and / or not understanding French
3. No prescription and/or contraindication to hydroxychloroquine
4. Systemic lupus outbreak with neurological impairment defined by SLEDAI score by a psychosis (disruption of normal activity in relation to a severe alteration of the perception of reality. Includes: hallucinations, incoherence, impoverishment of the content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic) or brain damage (with impairment of mental functions with impaired orientation, memory or other brutal appearance and fluctuating evolution).
5. History of psychiatric disorders: personality disorders, psychoses, severe depression
6. Hospitalization with a life-threatening clinical condition that does not allow to answer questions
7. Non affiliated patient or beneficiary of a social security scheme.
8. Patient refusing to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)	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.	Reflects the Plaquenil intake during the 40 previous days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients considered as observing and non-observing will be compared according to the activity of the disease	Activity of the disease : Systemic lupus considered as active for a SELENA-SLEDAI score ≥ 6	40 days
Patients considered as observing and non-observing will be compared according to number of prescribed medication		40 days
Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders	Presence of anxiety and/or depressive disorders, according to the Hospital Anxiety And Depression Scale (HAD), a score > to 10	40 days

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Investigators: Principal Investigator: Katlyne POLOMAT, MD, CHU of Martinique

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Actual): July 19, 2018
• Study Completion (Actual): July 19, 2018

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: systemic lupus erythematosus; observance; hydroxychloroquine dosage; risk factors of non-observance; SLICC score; SLEDAI score
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 16/B/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No