<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/NCT04402554</url>
  </required_header>
  <id_info>
    <org_study_id>RNI 2020 MATHIEU</org_study_id>
    <secondary_id>2020-A00473-36</secondary_id>
    <nct_id>NCT04402554</nct_id>
  </id_info>
  <brief_title>Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis</brief_title>
  <acronym>CannabisRIC</acronym>
  <official_title>Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      Patients with inflammatory rheumatism very often have residual pain that is not easily&#xD;
      relieved by conventional treatments. They can then use non-drug methods, such as&#xD;
      physiotherapy, hypnosis or even cannabis.&#xD;
&#xD;
      The aim of this study is to assess the percentage of patients who use cannabis to better&#xD;
      relieve their pain or anxiety in chronic inflammatory rheumatism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thanks to a better understanding of the pathophysiological mechanisms of inflammatory&#xD;
      rheumatism, rheumatology has known for several decades a growth in its therapeutic arsenal&#xD;
      (csDMARDs, bDMARDs, tDMARDs). rheumatism control has thus been optimized.&#xD;
&#xD;
      however, patients very often keep pain, anxiety, residual fatigue, poorly controlled by our&#xD;
      conventional therapies. patients then turn to non-drug therapies, among which the use of&#xD;
      cannabis.&#xD;
&#xD;
      endocannabinoids have an analgesic and anti-inflammatory action recognized in pre-clinical&#xD;
      trials. however, investigators currently lack the data to authorize its use in clinical&#xD;
      rheumatology.&#xD;
&#xD;
      the aim of this study is to determine the prevalence of cannabis users in patients with&#xD;
      rheumatoid arthritis, ankylosing spondyloarthritis or psoriatic arthritis in our unit. as a&#xD;
      second intention, investigators will refine the consumption characteristics. Investigators&#xD;
      will also look for possible risk factors for consumption (sensitivity to pain, catastrophism,&#xD;
      standard of living, anxiety, depression, rheumatic activity and quality of life).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2020</start_date>
  <completion_date type="Actual">March 19, 2021</completion_date>
  <primary_completion_date type="Actual">March 19, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of cannabis use in patients with chronic inflammatory rheumatic conditions</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients will answer the following question: Are you currently using cannabis - Yes or No</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with problematic cannabis use</measure>
    <time_frame>Day 0</time_frame>
    <description>Questionnaire CAST score. It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the association between cannabis use and disease activity of spondylitis ankylosing</measure>
    <time_frame>Day 0</time_frame>
    <description>Spondylitis ankylosing activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the association between cannabis use and disease activity of rheumatoid arthritis / psoriatic arthritis</measure>
    <time_frame>Day 0</time_frame>
    <description>Rheumatoid arthritis / psoriatic arthritis was assessed by Disease Activity Score including 28 joints (DAS 28). DAS 28 includes the 28 swollen joint count (28 SJC) + the 28 tender joint count (28 TJC) + patient global assessments of disease activity on a VAS, + ESR or CRP. [DAS (VS) = 0,56 x √TJC + 0,28 x √SJC + 0,7 x ln(VS) + 0,014 x VAS ; DAS (CRP) = 0,56 x √TJC + 0,28 x √SJC + 0,36 x ln(CRP + 1) + 0,014 x VAS + 0,96 ]. The scores according to EULAR criteria are: ≤2.6 for remission, &gt;2.6 and ≤3.2 for low disease activity, &gt;3.2 and ≤5.1 for moderate disease activity and &gt;5.1 for high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the association between cannabis use and functional disability</measure>
    <time_frame>Day 0</time_frame>
    <description>Functional disability was assessed by Health Assessment Questionnaire Disability Index (HAQ DI). HAQ-DI is an index that measures the impact of pathology on everyday activities such as dressing, eating, walking, etc.&#xD;
The following note is allocated to each question: 0 = without any difficulty ; 1 = with some difficulty ; 2 = with great difficulty ; 3 = unable to do so</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the association between cannabis use and Anxiety/Depression</measure>
    <time_frame>Day 0</time_frame>
    <description>Anxiety and depression was assessed by Hospital Anxiety and Depression scale (HADs). 14 items scored from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing two scores to be obtained (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D): - 7 or less: absence of symptoms - 8 to 10: doubtful symptoms - 11 and more: certain symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the association between cannabis use and pain catastrophism</measure>
    <time_frame>Day 0</time_frame>
    <description>Catastrophism was assessed by Pain catastrophisme scale (PCS). PCS is a thirteen-item scale to identify and quantify the extent of catastrophism in a painful patient. Three subgroups group together the criteria related to rumination (items 8,9,10,11), exaggeration (items 6,7,13) and vulnerability (items 1,2,3,4,5,12) . Patients are asked to rate their personal experience using a five-point rating from 0 to 4. The final score can therefore vary from 0 to 52. A PCS score of 30 or more represents a relevant clinical level of catastrophism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the association between cannabis use and social vulnerability</measure>
    <time_frame>Day 0</time_frame>
    <description>level of social vulnerability was assessed by Assessment of Precariousness and Health Inequalities in Health Examination Centers (EPICES) questionnaire.&#xD;
.</description>
  </secondary_outcome>
  <enrollment type="Actual">501</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Psoriatic Arthritis</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cannabis questionnaire</intervention_name>
    <description>The effectiveness and use of cannabis in the management of chronic pain has been well known for many years, but has so far been illegal and therefore largely unacknowledged. We hypothesize that the use of cannabis in this population of patients with chronic joint or spinal pain is not anecdotal and responds to a need to further improve the overall management of patients. The objective of our anonymous questionnaire is to estimate the prevalence of cannabis use in patients with chronic inflammatory rheumatism.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with Chronic Inflammatory Rheumatism, whether rheumatoid arthritis or&#xD;
        spondyloarthritis, seen in consultation in the department of Rheumatology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid Arthritis (ACR 2010 Criteria)&#xD;
&#xD;
          -  Ankylosing Spondylitis (New york or ASAS criteria)&#xD;
&#xD;
          -  Psoriatic Arthritis (CASPAR criteria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to complete questionnaires or unable to express informed consent&#xD;
&#xD;
          -  Guardianship, trusteeship, deprivation of liberties, safeguard of justice&#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>Sylvain Mathieu</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 1, 2021</last_update_submitted>
  <last_update_submitted_qc>June 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cannabis</keyword>
  <keyword>Cannabis/therapeutic use</keyword>
  <keyword>Cannabis/therapy</keyword>
  <keyword>Medical Marijuana</keyword>
  <keyword>Chronic Pain</keyword>
  <keyword>Rheumatic Diseases</keyword>
  <keyword>Arthritis, Rheumatoid</keyword>
  <keyword>Spondylitis, Ankylosing</keyword>
  <keyword>Arthritis, Psoriatic</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>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <!-- 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/NCT04402554
org study id: RNI 2020 MATHIEU
secondary id: 2020-A00473-36
nct id: NCT04402554
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with inflammatory rheumatism very often have residual pain that is not easily
      relieved by conventional treatments. They can then use non-drug methods, such as
      physiotherapy, hypnosis or even cannabis.

      The aim of this study is to assess the percentage of patients who use cannabis to better
      relieve their pain or anxiety in chronic inflammatory rheumatism.
Thanks to a better understanding of the pathophysiological mechanisms of inflammatory
      rheumatism, rheumatology has known for several decades a growth in its therapeutic arsenal
      (csDMARDs, bDMARDs, tDMARDs). rheumatism control has thus been optimized.

      however, patients very often keep pain, anxiety, residual fatigue, poorly controlled by our
      conventional therapies. patients then turn to non-drug therapies, among which the use of
      cannabis.

      endocannabinoids have an analgesic and anti-inflammatory action recognized in pre-clinical
      trials. however, investigators currently lack the data to authorize its use in clinical
      rheumatology.

      the aim of this study is to determine the prevalence of cannabis users in patients with
      rheumatoid arthritis, ankylosing spondyloarthritis or psoriatic arthritis in our unit. as a
      second intention, investigators will refine the consumption characteristics. Investigators
      will also look for possible risk factors for consumption (sensitivity to pain, catastrophism,
      standard of living, anxiety, depression, rheumatic activity and quality of life).
observational model: Cohort
time perspective: Other
measure: prevalence of cannabis use in patients with chronic inflammatory rheumatic conditions
time frame: Day 0
description: Patients will answer the following question: Are you currently using cannabis - Yes or No
measure: Percentage of patients with problematic cannabis use
time frame: Day 0
description: Questionnaire CAST score. It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7
measure: Assessing the association between cannabis use and disease activity of spondylitis ankylosing
time frame: Day 0
description: Spondylitis ankylosing activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.
measure: Assessing the association between cannabis use and disease activity of rheumatoid arthritis / psoriatic arthritis
time frame: Day 0
description: Rheumatoid arthritis / psoriatic arthritis was assessed by Disease Activity Score including 28 joints (DAS 28). DAS 28 includes the 28 swollen joint count (28 SJC) + the 28 tender joint count (28 TJC) + patient global assessments of disease activity on a VAS, + ESR or CRP. [DAS (VS) = 0,56 x √TJC + 0,28 x √SJC + 0,7 x ln(VS) + 0,014 x VAS ; DAS (CRP) = 0,56 x √TJC + 0,28 x √SJC + 0,36 x ln(CRP + 1) + 0,014 x VAS + 0,96 ]. The scores according to EULAR criteria are: ≤2.6 for remission, >2.6 and ≤3.2 for low disease activity, >3.2 and ≤5.1 for moderate disease activity and >5.1 for high disease activity.
measure: Assessing the association between cannabis use and functional disability
time frame: Day 0
description: Functional disability was assessed by Health Assessment Questionnaire Disability Index (HAQ DI). HAQ-DI is an index that measures the impact of pathology on everyday activities such as dressing, eating, walking, etc.
The following note is allocated to each question: 0 = without any difficulty ; 1 = with some difficulty ; 2 = with great difficulty ; 3 = unable to do so
measure: Assessing the association between cannabis use and Anxiety/Depression
time frame: Day 0
description: Anxiety and depression was assessed by Hospital Anxiety and Depression scale (HADs). 14 items scored from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing two scores to be obtained (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D): - 7 or less: absence of symptoms - 8 to 10: doubtful symptoms - 11 and more: certain symptoms.
measure: Assessing the association between cannabis use and pain catastrophism
time frame: Day 0
description: Catastrophism was assessed by Pain catastrophisme scale (PCS). PCS is a thirteen-item scale to identify and quantify the extent of catastrophism in a painful patient. Three subgroups group together the criteria related to rumination (items 8,9,10,11), exaggeration (items 6,7,13) and vulnerability (items 1,2,3,4,5,12) . Patients are asked to rate their personal experience using a five-point rating from 0 to 4. The final score can therefore vary from 0 to 52. A PCS score of 30 or more represents a relevant clinical level of catastrophism.
measure: Assessing the association between cannabis use and social vulnerability
time frame: Day 0
description: level of social vulnerability was assessed by Assessment of Precariousness and Health Inequalities in Health Examination Centers (EPICES) questionnaire.
.
intervention type: Behavioral
intervention name: Cannabis questionnaire
description: The effectiveness and use of cannabis in the management of chronic pain has been well known for many years, but has so far been illegal and therefore largely unacknowledged. We hypothesize that the use of cannabis in this population of patients with chronic joint or spinal pain is not anecdotal and responds to a need to further improve the overall management of patients. The objective of our anonymous questionnaire is to estimate the prevalence of cannabis use in patients with chronic inflammatory rheumatism.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sylvain Mathieu
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Marijuana Abuse