<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/NCT03039088</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A01288-39</org_study_id>
    <nct_id>NCT03039088</nct_id>
  </id_info>
  <brief_title>PREDICT-SpA - French Epidemiological Study of the Evaluation of the Impact of Fibromyalgia in the TNF Alpha Treatment Effect in Axial Spondyloarthritis in Both Anti-TNF naïve and - Experienced Patients</brief_title>
  <acronym>PREDICT_SpA</acronym>
  <official_title>PREDICT-SpA - French Epidemiological Study of the Evaluation of the Impact of Fibromyalgia in the TNF Alpha Treatment Effect in Axial Spondyloarthritis in Both Anti-TNF naïve and - Experienced Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association de Recherche Clinique en Rhumatologie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RCTs</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Association de Recherche Clinique en Rhumatologie</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>
      This is a prospective observational national (France) study with 2 visits 3 months apart&#xD;
      (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is&#xD;
      500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF&#xD;
      alpha blocker.&#xD;
&#xD;
      The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on&#xD;
      the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and&#xD;
      pre-exposed patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Diagnosis of SpA in the absence of objective signs of inflammation or structural&#xD;
      damage can be challenging, and especially difficult to differentiate from Fibromyalgia.&#xD;
      Furthermore, such patients can easily be classified as active and refractory to NSAIDs, and&#xD;
      inappropriately receive TNF alpha blockers.&#xD;
&#xD;
      Objective: Primary objective: To evaluate the impact of fibromyalgia in the TNF alpha&#xD;
      treatment effect in axial Spondyloarthritis in both anti-TNF naïve and - experienced&#xD;
      patients.&#xD;
&#xD;
      Methods: Design: Prospective observational national (France) study with 2 visits 3 months&#xD;
      apart (baseline and 12 weeks after TNF alpha blockers initiation). Patients: 500 SpA patients&#xD;
      (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker. Data&#xD;
      collection: items permitting the calculation of the ASAS criteria, the FIRST questionnaire&#xD;
      (Fibromyalgia Rapid Screen Test), patients and disease characteristics, disease activity and&#xD;
      severity items, and the domain leading the doctor's decision for initiating the TNF alpha&#xD;
      blocker (CRP/Imaging/Symptoms) will be collected at baseline. Effectiveness measures (e.g.&#xD;
      BASDAI and patient's global) and the doctor's decision to continue/discontinue the TNF alpha&#xD;
      blocker will be collected during the second visit. Statistical analysis: for the main&#xD;
      objective, evaluation of the predictive factors of a TNF alpha response in real life, and the&#xD;
      impact of Fibromyalgia in such response (e.g. logistic regression to estimate BASDAI&#xD;
      reduction of 50%). For the secondary objectives: evaluation of the relative attributable&#xD;
      risks of the doctor's domains leading the TNF alpha blocker initiation (Imaging/CRP/Symptoms)&#xD;
      in order to explain the anti-TNF therapy response; evaluation of the concordance existing&#xD;
      between the current recommendations and the daily practice.&#xD;
&#xD;
      Expected results: A positive finding might results into a change in the way of managing&#xD;
      patients (e.g. carefully checking for the co-existence of fibromyalgia before confirming a&#xD;
      spondyloarthritis diagnosis, an active disease and also before initiating a specific therapy&#xD;
      such as biologics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2014</start_date>
  <completion_date type="Actual">October 4, 2016</completion_date>
  <primary_completion_date type="Actual">October 4, 2016</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>To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire &gt;= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers</measure>
    <time_frame>At 12 weeks after TNF alpha blockers initiation</time_frame>
    <description>The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy</measure>
    <time_frame>At 12 weeks after TNF alpha blockers initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)</measure>
    <time_frame>At 12 weeks after TNF alpha blockers initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study.</measure>
    <time_frame>At baseline and at 12 weeks after TNF alpha blockers initiation</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">527</enrollment>
  <condition>Axial Spondyloarthritis</condition>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Fibromyalgia patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Not fibromyalgia patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up after 12 weeks after TNF alpha blockers initiation</intervention_name>
    <arm_group_label>Fibromyalgia patients</arm_group_label>
    <arm_group_label>Not fibromyalgia patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from SpA based on the opinion of the treating rheumatologist initiating&#xD;
        a TNF alpha blocker.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt; 18 years old and suffering from SpA based on the opinion of the&#xD;
             treating rheumatologist&#xD;
&#xD;
          -  Patients in whom the decision of initiating of switching an anti-TNF because of an&#xD;
             axial involvement of SpA has been made by the treating rheumatologist. In case of&#xD;
             previous exposure to antiTNF a washout period of at least 4 weeks be asked.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to understand the questionnaire&#xD;
&#xD;
          -  Patients not giving their informed written consent&#xD;
&#xD;
          -  Patients with absolute contraindications to anti-TNF as per label&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>January 9, 2018</results_first_submitted>
  <results_first_submitted_qc>January 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 19, 2018</results_first_posted>
  <last_update_submitted>January 9, 2018</last_update_submitted>
  <last_update_submitted_qc>January 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</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>Spondylitis</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Axial Spondyloarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenergic alpha-Antagonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fibromyalgia Patients</title>
          <description>202 (38.4%) according to the FiRST questionnaire.</description>
        </group>
        <group group_id="P2">
          <title>Not Fibromyalgia Patients</title>
          <description>324 (61.6%) according to the FiRST questionnaire</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="192"/>
                <participants group_id="P2" count="316"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="192"/>
                <participants group_id="P2" count="316"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fibromyalgia Patients</title>
          <description>According to the FiRST Questionnaire&#xD;
Follow-up after 12 weeks after TNF alpha blockers initiation</description>
        </group>
        <group group_id="B2">
          <title>Not Fibromyalgia Patients</title>
          <description>According to the FiRST Questionnaire&#xD;
Follow-up after 12 weeks after TNF alpha blockers initiation</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="202"/>
            <count group_id="B2" value="324"/>
            <count group_id="B3" value="526"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="202"/>
                    <measurement group_id="B2" value="324"/>
                    <measurement group_id="B3" value="526"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.6" spread="10.7"/>
                    <measurement group_id="B2" value="41.1" spread="12.1"/>
                    <measurement group_id="B3" value="41.3" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire &gt;= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers</title>
        <description>The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.</description>
        <time_frame>At 12 weeks after TNF alpha blockers initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fibromyalgia Patients</title>
            <description>192 (37.8%) according to the FiRST questionnaire.</description>
          </group>
          <group group_id="O2">
            <title>Not Fibromyalgia Patients</title>
          </group>
        </group_list>
        <measure>
          <title>To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire &gt;= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers</title>
          <description>The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="316"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy</title>
        <time_frame>At 12 weeks after TNF alpha blockers initiation</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)</title>
        <time_frame>At 12 weeks after TNF alpha blockers initiation</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study.</title>
        <time_frame>At baseline and at 12 weeks after TNF alpha blockers initiation</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Fibromyalgia Patients</title>
          <description>According to the FiRST Questionnaire&#xD;
Follow-up after 12 weeks after TNF alpha blockers initiation</description>
        </group>
        <group group_id="E2">
          <title>Not Fibromyalgia Patients</title>
          <description>According to the FiRST Questionnaire&#xD;
Follow-up after 12 weeks after TNF alpha blockers initiation</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Doctor Anna MOLTO</name_or_title>
      <organization>Rheumatology department, Cochin Hospital, APHP</organization>
      <phone>0158412617</phone>
      <email>anna.molto@aphp.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03039088
org study id: 2014-A01288-39
nct id: NCT03039088
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective observational national (France) study with 2 visits 3 months apart
      (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is
      500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF
      alpha blocker.

      The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on
      the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and
      pre-exposed patients.
Background: Diagnosis of SpA in the absence of objective signs of inflammation or structural
      damage can be challenging, and especially difficult to differentiate from Fibromyalgia.
      Furthermore, such patients can easily be classified as active and refractory to NSAIDs, and
      inappropriately receive TNF alpha blockers.

      Objective: Primary objective: To evaluate the impact of fibromyalgia in the TNF alpha
      treatment effect in axial Spondyloarthritis in both anti-TNF naïve and - experienced
      patients.

      Methods: Design: Prospective observational national (France) study with 2 visits 3 months
      apart (baseline and 12 weeks after TNF alpha blockers initiation). Patients: 500 SpA patients
      (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker. Data
      collection: items permitting the calculation of the ASAS criteria, the FIRST questionnaire
      (Fibromyalgia Rapid Screen Test), patients and disease characteristics, disease activity and
      severity items, and the domain leading the doctor's decision for initiating the TNF alpha
      blocker (CRP/Imaging/Symptoms) will be collected at baseline. Effectiveness measures (e.g.
      BASDAI and patient's global) and the doctor's decision to continue/discontinue the TNF alpha
      blocker will be collected during the second visit. Statistical analysis: for the main
      objective, evaluation of the predictive factors of a TNF alpha response in real life, and the
      impact of Fibromyalgia in such response (e.g. logistic regression to estimate BASDAI
      reduction of 50%). For the secondary objectives: evaluation of the relative attributable
      risks of the doctor's domains leading the TNF alpha blocker initiation (Imaging/CRP/Symptoms)
      in order to explain the anti-TNF therapy response; evaluation of the concordance existing
      between the current recommendations and the daily practice.

      Expected results: A positive finding might results into a change in the way of managing
      patients (e.g. carefully checking for the co-existence of fibromyalgia before confirming a
      spondyloarthritis diagnosis, an active disease and also before initiating a specific therapy
      such as biologics.
observational model: Cohort
time perspective: Prospective
measure: To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers
time frame: At 12 weeks after TNF alpha blockers initiation
description: The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
measure: The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy
time frame: At 12 weeks after TNF alpha blockers initiation
measure: Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)
time frame: At 12 weeks after TNF alpha blockers initiation
measure: Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study.
time frame: At baseline and at 12 weeks after TNF alpha blockers initiation
arm group label: Fibromyalgia patients
arm group label: Not fibromyalgia patients
intervention type: Other
intervention name: Follow-up after 12 weeks after TNF alpha blockers initiation
arm group label: Fibromyalgia patients
arm group label: Not fibromyalgia patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
mesh term: Adrenergic alpha-Antagonists
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 