Lupus and Observance

NCT ID: NCT03019926

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-19
• Study Completion Date: 2018-07-19

Brief Summary

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.

Conditions

Systemic Lupus, Skin Lupus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Hydroxychloroquine dosage

Blood sample from a 6 ml tube, performed in the common practice.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katlyne POLOMAT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU of Martinique

Locations

CHU de Martinique

Fort-de-France, Martinique, France

Countries

France

Other Identifiers

16/B/09

Identifier Type: -

Identifier Source: org_study_id