<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/NCT03027999</url>
  </required_header>
  <id_info>
    <org_study_id>2015/190/HP</org_study_id>
    <nct_id>NCT03027999</nct_id>
  </id_info>
  <brief_title>Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission</brief_title>
  <acronym>SIERRA</acronym>
  <official_title>Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission (or Low Disease Activity) Under Rituximab to Detect Early Relapse of the Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
      Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium&#xD;
      joints and, in the absence of appropriate background therapy, leads to progressive joint&#xD;
      destruction, functional, psychological, social and occupational repercussions.&#xD;
&#xD;
      Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to&#xD;
      evaluate the therapeutic response to RTX and re-administer it from the 24th week when the&#xD;
      goal of remission has not been achieved. However, the optimal modality for reprocessing&#xD;
      remains to be determined.&#xD;
&#xD;
      To this end, different approaches have been explored, such as lymphocyte typing or ultrasound&#xD;
      monitoring. The pace of these examinations, however, remains wide and their cost is not&#xD;
      negligible. This is why we propose here to explore the track of a tight follow-up nurse&#xD;
      DAS28.&#xD;
&#xD;
      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier&#xD;
      than the current medical follow-up.&#xD;
&#xD;
      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier&#xD;
      than the current medical follow-up&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference from baseline of disease activity specific score</measure>
    <time_frame>Every 3 months during 2 years</time_frame>
    <description>The disease activity specific score is DAS28-CRP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference from baseline in quality of life</measure>
    <time_frame>Every 3 months during 2 years</time_frame>
    <description>quality of life will be based on HAQ and SF36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cumulative dose of corticosteroids drugs received</measure>
    <time_frame>Every 3 months during 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cumulative dose of non-steroidal anti-inflammatory drugs received</measure>
    <time_frame>Every 3 months during 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Patient with tight nursing follow-up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compared as usual, Patient with tight nursing follow-up will be contacted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient without tight nursing follow-up</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Compared as usual, Patient without tight nursing follow-up will not have interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tight nursing follow-up</intervention_name>
    <description>In addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of&#xD;
a training session to self-assess their RA: Self-assessment of the number of painful and swollen joints, of pain and disease activity (global assessment by the patient) (self-DAS). During this session, a scheduled dosage of ESR and CRP levels will be given to the patient.&#xD;
A monthly call by a nurse who inquires about the results of the patient's self-assessment. As soon as she suspects a relapse of RA, she plans a consultation to confirm or not the relapse. For this purpose, she calculates the DAS28 taking into account the results of the biological test, the articular count and the disease activity. Clinical relapse is documented by a DAS28-CRP &gt; 2.7</description>
    <arm_group_label>Patient with tight nursing follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female (age 18 or older)&#xD;
&#xD;
          -  Rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria&#xD;
&#xD;
          -  Patient to whom the rheumatologist prescribed a treatment with rituximab or who&#xD;
             received a treatment with rituximab in the last 6 months&#xD;
&#xD;
          -  Patients with active rheumatoid arthritis prior to treatment with rituximab (DAS 28&#xD;
             CRP&gt;2.7)&#xD;
&#xD;
          -  Patient with a DAS 28 CRP of less than 2.7 at 6 months from the last administration of&#xD;
             rituximab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not responding to the last treatment with rituximab (DAS28 CRP&gt; 2.7 at 6&#xD;
             months)&#xD;
&#xD;
          -  Patient under the age of 18&#xD;
&#xD;
          -  Patient with chronic pain due to another pathology than rheumatoid arthritis, which&#xD;
             may interfere with the assessment&#xD;
&#xD;
          -  Patient with a contraindication to treatment with rituximab&#xD;
&#xD;
          -  Woman of childbearing age not taking effective contraception&#xD;
&#xD;
          -  Pregnant or nursing woman&#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>Olivier VITTECOQ, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deborah LEBEDIEFF, Nurse</last_name>
    <phone>+3323288</phone>
    <phone_ext>8265</phone_ext>
    <email>deborah.lebedieff@chu-rouen.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julien BLOT</last_name>
    <phone>+3323288</phone>
    <phone_ext>8265</phone_ext>
    <email>julien.blot@chu-rouen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian MARCELLI, Pr</last_name>
    </contact>
    <investigator>
      <last_name>Christian MARCELLI, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deborah LEBEDIEFF</last_name>
    </contact>
    <investigator>
      <last_name>Olivier VITTECOQ, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rituximab</keyword>
  <keyword>tight monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT03027999
org study id: 2015/190/HP
nct id: NCT03027999
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium
      joints and, in the absence of appropriate background therapy, leads to progressive joint
      destruction, functional, psychological, social and occupational repercussions.

      Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to
      evaluate the therapeutic response to RTX and re-administer it from the 24th week when the
      goal of remission has not been achieved. However, the optimal modality for reprocessing
      remains to be determined.

      To this end, different approaches have been explored, such as lymphocyte typing or ultrasound
      monitoring. The pace of these examinations, however, remains wide and their cost is not
      negligible. This is why we propose here to explore the track of a tight follow-up nurse
      DAS28.

      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier
      than the current medical follow-up.

      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier
      than the current medical follow-up
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Difference from baseline of disease activity specific score
time frame: Every 3 months during 2 years
description: The disease activity specific score is DAS28-CRP
measure: Difference from baseline in quality of life
time frame: Every 3 months during 2 years
description: quality of life will be based on HAQ and SF36 questionnaire
measure: Number of cumulative dose of corticosteroids drugs received
time frame: Every 3 months during 2 years
measure: Number of cumulative dose of non-steroidal anti-inflammatory drugs received
time frame: Every 3 months during 2 years
arm group label: Patient with tight nursing follow-up
arm group type: Experimental
description: Compared as usual, Patient with tight nursing follow-up will be contacted
arm group label: Patient without tight nursing follow-up
arm group type: No Intervention
description: Compared as usual, Patient without tight nursing follow-up will not have interventions
intervention type: Other
intervention name: tight nursing follow-up
description: In addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of
a training session to self-assess their RA: Self-assessment of the number of painful and swollen joints, of pain and disease activity (global assessment by the patient) (self-DAS). During this session, a scheduled dosage of ESR and CRP levels will be given to the patient.
A monthly call by a nurse who inquires about the results of the patient's self-assessment. As soon as she suspects a relapse of RA, she plans a consultation to confirm or not the relapse. For this purpose, she calculates the DAS28 taking into account the results of the biological test, the articular count and the disease activity. Clinical relapse is documented by a DAS28-CRP > 2.7
arm group label: Patient with tight nursing follow-up
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier VITTECOQ, Pr
role: Principal Investigator
affiliation: Rouen University Hospital
last name: Deborah LEBEDIEFF, Nurse
phone: +3323288
phone ext: 8265
email: deborah.lebedieff@chu-rouen.fr
last name: Julien BLOT
phone: +3323288
phone ext: 8265
email: julien.blot@chu-rouen.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No