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Completed

NCT Number: NCT03019926

Lupus and Observance

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.

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Key information

Conditions

Systemic Lupus, Skin Lupus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Martinique

Fort-de-France, Martinique, 97200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age <18 years or patient under guardianship
  • Patient not speaking and / or not understanding French
  • No prescription and/or contraindication to hydroxychloroquine
  • 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).
  • History of psychiatric disorders: personality disorders, psychoses, severe depression
  • Hospitalization with a life-threatening clinical condition that does not allow to answer questions
  • Non affiliated patient or beneficiary of a social security scheme.
  • Patient refusing to participate in the study

Treatment and study plan

Hydroxychloroquine dosage

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Patients considered as observing and non-observing will be compared according to number of prescribed medication

    Time frame: 40 days

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Acronym: LUPOBS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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