<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/NCT01730495</url>
  </required_header>
  <id_info>
    <org_study_id>2011/2500</org_study_id>
    <secondary_id>2011-006069-16</secondary_id>
    <nct_id>NCT01730495</nct_id>
  </id_info>
  <brief_title>Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome</brief_title>
  <official_title>Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no Clinical Response After B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic&#xD;
      encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell&#xD;
      depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis&#xD;
      factor-alpha inhibition using Etanercept as weekly subcutaneous injections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    After inclusion of four patients, two experienced moderate worsening of symptoms&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.</measure>
    <time_frame>Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.</time_frame>
    <description>The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.</measure>
    <time_frame>At 3, 6, 9, 12 months after start of intervention.</time_frame>
    <description>The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Chronic Fatigue Syndrome</condition>
  <condition>Myalgic Encephalomyelitis</condition>
  <arm_group>
    <arm_group_label>Etanercept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etanercept</intervention_name>
    <description>Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.</description>
    <arm_group_label>Etanercept</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)&#xD;
&#xD;
          -  moderate and serious CFS/ME severity&#xD;
&#xD;
          -  age 18-66 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with fatigue, not fulfilling criteria for CFS&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma&#xD;
             in situ&#xD;
&#xD;
          -  previous long-term systemic treatment with immunosuppressive drugs such as&#xD;
             cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive&#xD;
             lunge disease.&#xD;
&#xD;
          -  demyelinating disease, such as multiple sclerosis.&#xD;
&#xD;
          -  heart failure.&#xD;
&#xD;
          -  endogenous depression.&#xD;
&#xD;
          -  lack of ability to comply to the protocol.&#xD;
&#xD;
          -  multi-allergy with risk of serious drug reaction&#xD;
&#xD;
          -  reduced renal function (creatinine &gt; 1.5 x UNL)&#xD;
&#xD;
          -  reduced liver function (bilirubin or transaminases &gt; 1.5 x UNL)&#xD;
&#xD;
          -  HIV positivity. Evidence of clinically significant infection. Previous viral hepatitis&#xD;
             with risk of reactivation. High risk of opportunistic infections. Latent tuberculosis&#xD;
             must be treated before inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Øystein Fluge, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Oncology and Medical Physics, Haukeland University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway</name>
      <address>
        <city>Bergen</city>
        <zip>N-5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.</citation>
    <PMID>22039471</PMID>
  </reference>
  <reference>
    <citation>Fluge O, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28.</citation>
    <PMID>19566965</PMID>
  </reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic fatigue syndrome</keyword>
  <keyword>CFS</keyword>
  <keyword>Myalgic Encephalomyelitis (ME)</keyword>
  <keyword>CFS/ME</keyword>
  <keyword>Tumor necrosis factor-alpha</keyword>
  <keyword>TNF-alpha</keyword>
  <keyword>Etanercept</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Encephalomyelitis</mesh_term>
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
  </intervention_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/NCT01730495
org study id: 2011/2500
secondary id: 2011-006069-16
nct id: NCT01730495
lead sponsor: 
has dmc: No
The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic
      encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell
      depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis
      factor-alpha inhibition using Etanercept as weekly subcutaneous injections.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
time frame: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
description: The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
measure: Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
time frame: At 3, 6, 9, 12 months after start of intervention.
description: The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.
arm group label: Etanercept
arm group type: Experimental
intervention type: Drug
intervention name: Etanercept
description: Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
arm group label: Etanercept
criteria: 
gender: All
minimum age: 18 Years
maximum age: 66 Years
healthy volunteers: No
last name: Øystein Fluge, MD, PhD
role: Principal Investigator
affiliation: Dept. of Oncology and Medical Physics, Haukeland University Hospital
facility: 
country: Norway
citation: Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.
PMID: 22039471
citation: Fluge O, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28.
PMID: 19566965
responsible party type: Sponsor
mesh term: Encephalomyelitis
mesh term: Fatigue Syndrome, Chronic
mesh term: Myalgia
mesh term: Syndrome
mesh term: Fatigue
mesh term: Necrosis
mesh term: Etanercept