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Trial record 76 of 914 for:    Lupus

Lupus and Observance (LUPOBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03019926
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : August 1, 2019
Information provided by (Responsible Party):
University Hospital Center of Martinique

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.

Condition or disease Intervention/treatment
Systemic Lupus, Skin Lupus Biological: Hydroxychloroquine dosage

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lupus and Observance
Actual Study Start Date : January 19, 2017
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Intervention Details:
  • Biological: Hydroxychloroquine dosage
    Blood sample from a 6 ml tube, performed in the common practice.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03019926

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CHU de Martinique
Fort-de-France, Martinique, France, 97200
Sponsors and Collaborators
University Hospital Center of Martinique
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Principal Investigator: Katlyne POLOMAT, MD CHU of Martinique

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Responsible Party: University Hospital Center of Martinique Identifier: NCT03019926     History of Changes
Other Study ID Numbers: 16/B/09
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Center of Martinique:
systemic lupus erythematosus
hydroxychloroquine dosage
risk factors of non-observance
SLICC score
SLEDAI score
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents