<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03019926</url>
  </required_header>
  <id_info>
    <org_study_id>16/B/09</org_study_id>
    <nct_id>NCT03019926</nct_id>
  </id_info>
  <brief_title>Lupus and Observance</brief_title>
  <acronym>LUPOBS</acronym>
  <official_title>Lupus and Observance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is&#xD;
      associated with an increased risk of relapses, hospitalizations, morbidity and poor renal&#xD;
      prognosis.&#xD;
&#xD;
      New treatment protocols exist and are indicated in second intention in case of good&#xD;
      compliance. An assessment of therapeutic adherence is therefore essential.&#xD;
&#xD;
      Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been&#xD;
      prescribed with Plaquenil (hydroxychloroquine), will be included in the study.&#xD;
&#xD;
      The study primary objective is to determine risk factors for non-observance&#xD;
&#xD;
      The secondary objectives are to:&#xD;
&#xD;
        -  Measure the observance rate of patients with systemic lupus in Martinique.&#xD;
&#xD;
        -  Describe the parameters that influence observance: evaluation of the disease and&#xD;
           associated comorbidities, psychosocial assessment, assessment of the doctor-patient&#xD;
           relationship, evaluation of the disease representations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">July 19, 2018</completion_date>
  <primary_completion_date type="Actual">July 19, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)</measure>
    <time_frame>Reflects the Plaquenil intake during the 40 previous days</time_frame>
    <description>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.&#xD;
A dosage below 200 ng/ml or 0.2 mg/l defines a non-observing patient within the 40 days above.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients considered as observing and non-observing will be compared according to the activity of the disease</measure>
    <time_frame>40 days</time_frame>
    <description>Activity of the disease : Systemic lupus considered as active for a SELENA-SLEDAI score ≥ 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients considered as observing and non-observing will be compared according to number of prescribed medication</measure>
    <time_frame>40 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders</measure>
    <time_frame>40 days</time_frame>
    <description>Presence of anxiety and/or depressive disorders, according to the Hospital Anxiety And Depression Scale (HAD), a score &gt; to 10</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Systemic Lupus, Skin Lupus</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hydroxychloroquine dosage</intervention_name>
    <description>Blood sample from a 6 ml tube, performed in the common practice.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will is proposed to anyone aged 18 years or older with a diagnosis of systemic&#xD;
        lupus or skin lupus for at least 6 months, ans who has been prescribed with&#xD;
        hydroxychloroquine (Plaquenil) for at least 6 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Systemic lupus defined according to the diagnostic criteria of the American College of&#xD;
             Rheumatology &quot; 1997, diagnosed for at least 6 months; Or Skin Lupus&#xD;
&#xD;
          3. Consultation or hospitalization at the University Hospital of Martinique, in either&#xD;
             services of Internal Medicine, Rheumatology or Dermatology.&#xD;
&#xD;
          4. Prescription of hydroxychloroquine (Plaquenil®) for at least 6 months&#xD;
&#xD;
          5. Affiliate or beneficiary of a social security scheme.&#xD;
&#xD;
          6. Patient not opposed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18 years or patient under guardianship&#xD;
&#xD;
          2. Patient not speaking and / or not understanding French&#xD;
&#xD;
          3. No prescription and/or contraindication to hydroxychloroquine&#xD;
&#xD;
          4. Systemic lupus outbreak with neurological impairment defined by SLEDAI score by a&#xD;
             psychosis (disruption of normal activity in relation to a severe alteration of the&#xD;
             perception of reality. Includes: hallucinations, incoherence, impoverishment of the&#xD;
             content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic)&#xD;
             or brain damage (with impairment of mental functions with impaired orientation, memory&#xD;
             or other brutal appearance and fluctuating evolution).&#xD;
&#xD;
          5. History of psychiatric disorders: personality disorders, psychoses, severe depression&#xD;
&#xD;
          6. Hospitalization with a life-threatening clinical condition that does not allow to&#xD;
             answer questions&#xD;
&#xD;
          7. Non affiliated patient or beneficiary of a social security scheme.&#xD;
&#xD;
          8. Patient refusing to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katlyne POLOMAT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU of Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <state>Martinique</state>
        <zip>97200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>systemic lupus erythematosus</keyword>
  <keyword>observance</keyword>
  <keyword>hydroxychloroquine dosage</keyword>
  <keyword>risk factors of non-observance</keyword>
  <keyword>SLICC score</keyword>
  <keyword>SLEDAI score</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxychloroquine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03019926
org study id: 16/B/09
nct id: NCT03019926
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)
time frame: Reflects the Plaquenil intake during the 40 previous days
description: 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.
measure: Patients considered as observing and non-observing will be compared according to the activity of the disease
time frame: 40 days
description: Activity of the disease : Systemic lupus considered as active for a SELENA-SLEDAI score ≥ 6
measure: Patients considered as observing and non-observing will be compared according to number of prescribed medication
time frame: 40 days
measure: Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders
time frame: 40 days
description: Presence of anxiety and/or depressive disorders, according to the Hospital Anxiety And Depression Scale (HAD), a score > to 10
intervention type: Biological
intervention name: Hydroxychloroquine dosage
description: Blood sample from a 6 ml tube, performed in the common practice.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katlyne POLOMAT, MD
role: Principal Investigator
affiliation: CHU of Martinique
facility: 
country: France
responsible party type: Sponsor
mesh term: Hydroxychloroquine
sharing ipd: No