<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/NCT04499001</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01380-39</org_study_id>
    <nct_id>NCT04499001</nct_id>
  </id_info>
  <brief_title>Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs</brief_title>
  <official_title>Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis Treated With Subcutaneous Biologic DMARDs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Cochin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Cochin</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>
      There is a lack of knowledge among patients concerning their treatment with bDMARDs. To&#xD;
      increase knowledge and safety skills, patient education is essential.&#xD;
&#xD;
      The aim of this study is to assess the impact of a pharmacist's educational interview on on&#xD;
      knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, controlled, open-label and monocentric study. 60 patients are&#xD;
      planned to be included.&#xD;
&#xD;
      Knowledge are assessed three time by self-administered questionnaire:&#xD;
&#xD;
      at baseline before the pharmacist's educational interview at three months apart at six months&#xD;
      apart&#xD;
&#xD;
      One primary end-point is defined:&#xD;
&#xD;
      the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous&#xD;
      bDMARD management (self-administered questionnaire, Biosecure)&#xD;
&#xD;
      As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence,&#xD;
      patients' satisfaction regarding the pharmacists' intervention and the effect of the&#xD;
      interview on rate of patients treated by biosimilar are evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation</measure>
    <time_frame>6 months of follow-up</time_frame>
    <description>Knowledge level and score comparison (good or moderate or bad knowledge) evaluated by self-questionnaire (Biosecure) from baseline to M3 and M6 after the pharmaceutical consultation.&#xD;
Biosecure : Minimum = 0 ; Maximum = 100 Good knowledge &gt; 84 Moderate knoledge : 64 to 84 Bad knowledge &lt; 64&#xD;
Higher scores mean a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation</measure>
    <time_frame>6 months of follow-up</time_frame>
    <description>Adherence level comparison (high or low adherence) evaluated by self-questionnaire, Compliance Questionnaire for Rheumatology (CQR-5) from baseline to M3 and M6 after the consultation.&#xD;
High adherence means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of patients on the pharmaceutical interview 3 months apart</measure>
    <time_frame>3 months of follow-up</time_frame>
    <description>Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in rate of patients treated by biosimilar after the pharmaceutical consultation</measure>
    <time_frame>6 months of follow-up</time_frame>
    <description>Comparison of patient treated by biosimilar rate from baseline to M3 and M6 after the consultation</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <condition>Spondyloarthritis</condition>
  <condition>Biological Therapy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacist's consultation</intervention_name>
    <description>Information about bDMARDs management.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with subcutaneous bDMARDs with inflammatory arthritis admitted in medical&#xD;
        consultation in the rheumatology department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be able to understand and communicate in French and comply with the&#xD;
             requirements of the study and must give his agreement (non-opposition) before any&#xD;
             study assessment is performed.&#xD;
&#xD;
          -  Patient at least 18 years of age&#xD;
&#xD;
          -  Patient with inflammatory arthritis (rheumatoid arthritis or ankylosing spondylitis or&#xD;
             other)&#xD;
&#xD;
          -  Admission in medical consultation in the rheumatology department&#xD;
&#xD;
          -  Patient treated with subcutaneous biologic DMARDs (Tocilizumab, Adalimumab,&#xD;
             Etanercept, Golimumab, Certolizumab, Abatacept, Sarilumab, Ustekinumab, Ixekizumab,&#xD;
             Anakinra)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical or psychiatric condition which, in the Investigator's opinion, would&#xD;
             preclude the participant from completing the study per protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Cécile Bottois, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Cochin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cécile Bottois, Dr</last_name>
    <phone>+33 1 58 41 23 02</phone>
    <email>cecile.bottois@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ornella Conort, Dr</last_name>
    <phone>+ 33 1 58 41 23 07</phone>
    <email>ornella.conort@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cécile Bottois, Dr</last_name>
      <phone>+33 1 58 41 23 02</phone>
      <email>cecile.bottois@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Ornella Conort, Dr</last_name>
      <phone>+33 1 58 41 23 07</phone>
      <email>ornella.conort@aphp.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Cécile Bottois, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ornella Conort, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maxime Dougados, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Cochin</investigator_affiliation>
    <investigator_full_name>Cécile Bottois</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>knowledge</keyword>
  <keyword>safety skills</keyword>
  <keyword>pharmaceutical consultation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_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/NCT04499001
org study id: 2020-A01380-39
nct id: NCT04499001
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a lack of knowledge among patients concerning their treatment with bDMARDs. To
      increase knowledge and safety skills, patient education is essential.

      The aim of this study is to assess the impact of a pharmacist's educational interview on on
      knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.
This is an observational, controlled, open-label and monocentric study. 60 patients are
      planned to be included.

      Knowledge are assessed three time by self-administered questionnaire:

      at baseline before the pharmacist's educational interview at three months apart at six months
      apart

      One primary end-point is defined:

      the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous
      bDMARD management (self-administered questionnaire, Biosecure)

      As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence,
      patients' satisfaction regarding the pharmacists' intervention and the effect of the
      interview on rate of patients treated by biosimilar are evaluated.
observational model: Other
time perspective: Prospective
measure: Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation
time frame: 6 months of follow-up
description: Knowledge level and score comparison (good or moderate or bad knowledge) evaluated by self-questionnaire (Biosecure) from baseline to M3 and M6 after the pharmaceutical consultation.
Biosecure : Minimum = 0 ; Maximum = 100 Good knowledge > 84 Moderate knoledge : 64 to 84 Bad knowledge < 64
Higher scores mean a better outcome.
measure: Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation
time frame: 6 months of follow-up
description: Adherence level comparison (high or low adherence) evaluated by self-questionnaire, Compliance Questionnaire for Rheumatology (CQR-5) from baseline to M3 and M6 after the consultation.
High adherence means a better outcome.
measure: Satisfaction of patients on the pharmaceutical interview 3 months apart
time frame: 3 months of follow-up
description: Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation.
measure: Change in rate of patients treated by biosimilar after the pharmaceutical consultation
time frame: 6 months of follow-up
description: Comparison of patient treated by biosimilar rate from baseline to M3 and M6 after the consultation
intervention type: Other
intervention name: Pharmacist's consultation
description: Information about bDMARDs management.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Cécile Bottois, Dr
role: Principal Investigator
affiliation: Hôpital Cochin
last name: Cécile Bottois, Dr
phone: +33 1 58 41 23 02
email: cecile.bottois@aphp.fr
last name: Ornella Conort, Dr
phone: + 33 1 58 41 23 07
email: ornella.conort@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital Cochin
investigator full name: Cécile Bottois
investigator title: Principal Investigator
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Spondylarthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No