<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/NCT03768271</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180024</org_study_id>
    <nct_id>NCT03768271</nct_id>
  </id_info>
  <brief_title>APACHE Cohort (A Psoriatic Arthritis CoHort)</brief_title>
  <acronym>APACHE</acronym>
  <official_title>French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease, belonging to the wide&#xD;
      spectrum of spondyloarthritis, but with the particularity to be associated with personal&#xD;
      psoriasis or familial psoriasis. PsA can be a very disabling disease through progressive and&#xD;
      irreversible joint damage. Long-term functional prognosis of patients with PsA is correlated&#xD;
      with the presence and severity of the radiographic joint lesions of the disease.&#xD;
&#xD;
      However, the proportion of patients who will develop those peripheral joint damages is not&#xD;
      yet known and less over the factors which are associated/involved in such an aggressive&#xD;
      pattern of the disease. Early identification of this subgroup of patients is particularly&#xD;
      important for determining early &quot;intensive&quot; treatment, strict management with a Treat To&#xD;
      Target approach, and identification of new treatments with a stronger structural effect.&#xD;
&#xD;
      The main objective of this prospective 10 years cohort is to describe the 5 years structural&#xD;
      (radiographic) severity of recent PsA with recent peripheral arthritis.Some of the secondary&#xD;
      objectives are to describe the 10 years structural severity within those patients, and to&#xD;
      determine the predictive factors of those 5 and 10 years radiographic lesions (genetic,&#xD;
      environmental, clinic, therapeutic factors).&#xD;
&#xD;
      APACHE will provide a unique longitudinal standardized database concerning patients with PsA&#xD;
      with very recent peripheral arthritis. Research projects which will based on those collected&#xD;
      data should allow to identify the mechanisms of aggressive joint damage, to highlight mew&#xD;
      treatments targets, to better describe the burden of the disease, to test previous or develop&#xD;
      new assessments tolls, to develop early diagnostic criteria&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method:APACHE is a prospective national multicentre (29) cohort including and following&#xD;
      during 10 years patients with a first peripheral arthritis in the past year, attributing to a&#xD;
      PsA according to the treating rheumatologist. 425 patients will be included during a 4 years&#xD;
      period before the follow-up. Standardized visits are planned throughout the 10 years&#xD;
      follow-up, permitting the collection of various data:&#xD;
&#xD;
        -  clinical data&#xD;
&#xD;
        -  Patients Reported Outcome&#xD;
&#xD;
        -  usual lab parameters&#xD;
&#xD;
        -  plasma, serum and urines&#xD;
&#xD;
        -  Baseline and one year RNA, DNA&#xD;
&#xD;
        -  peripheral X-Rays, Ultrasounds and MRI at different time points Those visits have non&#xD;
           interventional character (no therapeutic decision will be taken) Those collected data&#xD;
           will allow submissions of many research projects to the scientific committee of the&#xD;
           cohort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 12, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2034</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2028</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>Percentage of patients with at least one erosion on the 5-years X-Rays</measure>
    <time_frame>at 5 years</time_frame>
    <description>The primary endpoint is the presence / absence of at least one erosion on at least one of the 5-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline.&#xD;
The assessment of erosions will be done by 3 trained readers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with at least one joint space narrowing and one periostitic lesion on the 5-years X-Rays.</measure>
    <time_frame>at 5 years</time_frame>
    <description>this endpoint is the presence of at least one joint space narrowing and one periostitic lesion on at least one of the 5-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline. The assessment of erosions will be done by 3 trained readers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with at least one erosion, joint space narrowing, periostitic lesion, on the 10-years X-Rays.</measure>
    <time_frame>at 10 years</time_frame>
    <description>this endpoint is the presence of at least one erosion, joint space narrowing, periostitic lesion, on at least one of the 10-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline. The assessment of erosions will be done by 3 trained readers.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">425</enrollment>
  <condition>Cohort Study</condition>
  <condition>Psoriatic Arthritis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma, serum, urine, DNA, RNA.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with peripheral psoriatic arthritis diagnosed at an early stage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women or men aged from 18 to 60 inclusive&#xD;
&#xD;
          -  First episode of peripheral arthritis in the last 12 months, authenticated by a&#xD;
             rheumatologist&#xD;
&#xD;
          -  Psoriasis diagnosed by a practitioner or family history of psoriatic arthritis&#xD;
             (first-degree relative [parent or sibling] or second degree relative)&#xD;
&#xD;
          -  Arthritis most likely recognized as a psoriatic arthritis by a rheumatologist&#xD;
             (diagnostic confidence score : ≥ 7 out of 10)&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
          -  Affiliation to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Formal diagnostic of inflammatory rheumatism other than psoriatic arthritis&#xD;
&#xD;
          -  Treatment or history of treatment with a biomedicine&#xD;
&#xD;
          -  Patient receiving csDMARDS or apremilast treatment for 1 year or more&#xD;
&#xD;
          -  Patient having received csDMARDS or apremilast treatment during the last 12 months&#xD;
&#xD;
          -  Oral steroids in the last 4 weeks, above 10 mg/d of prednisone or with modified dosage&#xD;
&#xD;
          -  intravenous or intra articular steroids in the last 4 weeks&#xD;
&#xD;
          -  IRM contraindication&#xD;
&#xD;
          -  Cognitive, mental or psychic disorders impeding protocol accomplishment&#xD;
&#xD;
          -  Difficulties with French language understanding&#xD;
&#xD;
          -  Patient under tutorship or curatorship&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle VIVALDO</last_name>
    <role>Study Chair</role>
    <affiliation>DRCD-Assistance Publique des Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pascal CLAUDEPIERRE, PHD</last_name>
    <phone>01 49 81 47 04</phone>
    <phone_ext>0033</phone_ext>
    <email>pascal.claudepierre@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Henri-Mondor Hospital</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal Claudepierre</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lapeyronie Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34090</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cédric LUKAS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabienne ROUX</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>July 5, 2022</last_update_submitted>
  <last_update_submitted_qc>July 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</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/NCT03768271
org study id: APHP180024
nct id: NCT03768271
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease, belonging to the wide
      spectrum of spondyloarthritis, but with the particularity to be associated with personal
      psoriasis or familial psoriasis. PsA can be a very disabling disease through progressive and
      irreversible joint damage. Long-term functional prognosis of patients with PsA is correlated
      with the presence and severity of the radiographic joint lesions of the disease.

      However, the proportion of patients who will develop those peripheral joint damages is not
      yet known and less over the factors which are associated/involved in such an aggressive
      pattern of the disease. Early identification of this subgroup of patients is particularly
      important for determining early "intensive" treatment, strict management with a Treat To
      Target approach, and identification of new treatments with a stronger structural effect.

      The main objective of this prospective 10 years cohort is to describe the 5 years structural
      (radiographic) severity of recent PsA with recent peripheral arthritis.Some of the secondary
      objectives are to describe the 10 years structural severity within those patients, and to
      determine the predictive factors of those 5 and 10 years radiographic lesions (genetic,
      environmental, clinic, therapeutic factors).

      APACHE will provide a unique longitudinal standardized database concerning patients with PsA
      with very recent peripheral arthritis. Research projects which will based on those collected
      data should allow to identify the mechanisms of aggressive joint damage, to highlight mew
      treatments targets, to better describe the burden of the disease, to test previous or develop
      new assessments tolls, to develop early diagnostic criteria
Method:APACHE is a prospective national multicentre (29) cohort including and following
      during 10 years patients with a first peripheral arthritis in the past year, attributing to a
      PsA according to the treating rheumatologist. 425 patients will be included during a 4 years
      period before the follow-up. Standardized visits are planned throughout the 10 years
      follow-up, permitting the collection of various data:

        -  clinical data

        -  Patients Reported Outcome

        -  usual lab parameters

        -  plasma, serum and urines

        -  Baseline and one year RNA, DNA

        -  peripheral X-Rays, Ultrasounds and MRI at different time points Those visits have non
           interventional character (no therapeutic decision will be taken) Those collected data
           will allow submissions of many research projects to the scientific committee of the
           cohort.
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients with at least one erosion on the 5-years X-Rays
time frame: at 5 years
description: The primary endpoint is the presence / absence of at least one erosion on at least one of the 5-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline.
The assessment of erosions will be done by 3 trained readers.
measure: Percentage of patients with at least one joint space narrowing and one periostitic lesion on the 5-years X-Rays.
time frame: at 5 years
description: this endpoint is the presence of at least one joint space narrowing and one periostitic lesion on at least one of the 5-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline. The assessment of erosions will be done by 3 trained readers.
measure: Percentage of patients with at least one erosion, joint space narrowing, periostitic lesion, on the 10-years X-Rays.
time frame: at 10 years
description: this endpoint is the presence of at least one erosion, joint space narrowing, periostitic lesion, on at least one of the 10-years X-Rays, i.e., wrists and hands, feet, and if present other joint(s) with arthritis at baseline. The assessment of erosions will be done by 3 trained readers.
plasma, serum, urine, DNA, RNA.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Isabelle VIVALDO
role: Study Chair
affiliation: DRCD-Assistance Publique des Hôpitaux de Paris
last name: Pascal CLAUDEPIERRE, PHD
phone: 01 49 81 47 04
phone ext: 0033
email: pascal.claudepierre@aphp.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
sharing ipd: No