<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/NCT01697202</url>
  </required_header>
  <id_info>
    <org_study_id>GoteborgU</org_study_id>
    <nct_id>NCT01697202</nct_id>
  </id_info>
  <brief_title>Fatigue in Rheumatoid Arthritis - Longitudinal Study</brief_title>
  <official_title>Fatigue in Rheumatoid Arthritis - Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and&#xD;
      which factors that may influence the fatigue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>4 times during the course of the study up to one year</time_frame>
    <description>patient administered questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>4 times during the course of the study up to one year</time_frame>
    <description>patient administered questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity limitations</measure>
    <time_frame>4 times during the course of the study up to one year</time_frame>
    <description>patient administered questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity</measure>
    <time_frame>4 times during the course of the study up to one year</time_frame>
    <description>Tender and swollen joint count, patient-rated global health, inflammation parameters (DAS-28)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>4 times during the course of the study upto one year</time_frame>
    <description>patient administered questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Fatigue</condition>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Persons with RA at the Rheumatology clinic at Sahlgrenska University hospital Gothenburg,&#xD;
        Sweden&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnose of RA, age 20-65 years,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other serious physical or mental illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>February 19, 2014</last_update_submitted>
  <last_update_submitted_qc>February 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2014</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, Rheumatoid</mesh_term>
    <mesh_term>Fatigue</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/NCT01697202
org study id: GoteborgU
nct id: NCT01697202
lead sponsor: 
has dmc: No
To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and
      which factors that may influence the fatigue.
observational model: Case-Only
time perspective: Prospective
measure: Fatigue
time frame: 4 times during the course of the study up to one year
description: patient administered questionnaire
measure: Pain
time frame: 4 times during the course of the study up to one year
description: patient administered questionnaire
measure: Activity limitations
time frame: 4 times during the course of the study up to one year
description: patient administered questionnaire
measure: Disease activity
time frame: 4 times during the course of the study up to one year
description: Tender and swollen joint count, patient-rated global health, inflammation parameters (DAS-28)
measure: Health related quality of life
time frame: 4 times during the course of the study upto one year
description: patient administered questionnaire
arm group label: no intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Fatigue