<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/NCT02229942</url>
  </required_header>
  <id_info>
    <org_study_id>KTS-6-2014</org_study_id>
    <secondary_id>2014-000795-25</secondary_id>
    <secondary_id>229035</secondary_id>
    <nct_id>NCT02229942</nct_id>
  </id_info>
  <brief_title>B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.</brief_title>
  <acronym>RituxME</acronym>
  <official_title>B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Multicentre, Randomized, Double-blind and Placebo Controlled Phase-III Study With Rituximab Induction and Maintenance Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Department of Health and Social Affairs</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Kavli Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Trondheim University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Telemark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MEandYou Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Norwegian ME association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic&#xD;
      Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from&#xD;
      B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and&#xD;
      maintenance treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We have published a case series of pilot patient observations with B-cell depletion in&#xD;
      Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) (Fluge and Mella, BMC Neurol,&#xD;
      2009). Subsequently, we published a small randomized and double-blind phase II study using&#xD;
      rituximab induction two infusions two weeks apart (Fluge et al, Plos One, 2011).&#xD;
&#xD;
      We have completed an open label phase II study with 29 patients using rituximab induction and&#xD;
      maintenance treatment (six rituximab infusions over 15 months, with follow-up for three&#xD;
      years, unpublished).&#xD;
&#xD;
      We hypothesize that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic&#xD;
      Encephalopathy (CFS/ME) have a chronically activated immune system involving B-lymphocytes,&#xD;
      possibly a variant of an autoimmune disease, and that patients may benefit from B-cell&#xD;
      depletion therapy.&#xD;
&#xD;
      Three substudies will be performed:&#xD;
&#xD;
      Endothelial function: assessment of Flow-Mediated Dilation and skin microcirculation at&#xD;
      baseline and repeated during the time interval 17-21 months.&#xD;
&#xD;
      Cardiopulmonary exercise test for two following days: assessment at baseline and repeated&#xD;
      during the time interval 17-21 months.&#xD;
&#xD;
      Gastrointestinal function: assessment at baseline and repeated during the time interval 17-21&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue score, selfreported.</measure>
    <time_frame>Course of Fatigue score during 24 months follow-up.</time_frame>
    <description>Selfreported Fatigue score is registered every second week, as the mean score for the four symptoms: &quot;Post-exertional malaise&quot;, &quot;Fatigue&quot;, &quot;Need for rest&quot;, &quot;Daily functioning&quot; (scale 0-6). Mean Fatigue scores for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are recorded for each patient. These data are used for statistical analysis. The difference in course of Fatigue score during 24 months follow-up, between the rituximab and placebo groups, will constitute the primary endpoint.&#xD;
Overall response is recorded as the effect on CFS/ME symptoms during 24 months follow-up. The overall response is not predefined to a specific time interval, but is defined as mean Fatigue score at least 4.5 for at least 8 consecutive weeks for moderate response, and mean Fatigue score at least 5.0 for at least 8 consecutive weeks for major response. Single response periods and the sum of response periods during 24 months follow-up will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36)</measure>
    <time_frame>Changes in SF-36 scores during 24 months follow-up</time_frame>
    <description>SF-36 (ver 1.2) are selfreported by patients at baseline, and at 3, 6, 9, 12, 15, 18, 21 and 24 months follow-up. Changes in Physical health summary score, Physical function, and &quot;Mean of five subdimensions&quot; (Physical function, Bodily pain, Vitality, Social function, General health) are recorded. The difference in course during 24 months follow-up, between the rituximab and placebo groups, will constitute secondary endpoints.&#xD;
Also, the difference between rituximab and placebo groups, in changes from baseline to recording at 18 months, for Physical health summary score, Physical function, and &quot;mean of five SF-36 subdimensions&quot;, constitute secondary endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity (Sensewear armband)</measure>
    <time_frame>Analyzed at baseline and at interval 17-21 months</time_frame>
    <description>The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 17-21 months follow-up. Changes from baseline to analysis during the time interval 17-21 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. The difference between rituximab and placebo groups will constitute secondary endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-recorded &quot;Function level&quot;</measure>
    <time_frame>Course during 24 months follow-up</time_frame>
    <description>Self-recorded &quot;Function level&quot; (scale 0-100, compared to healthy state, according to a set of examples) are registered every second week. Mean &quot;Function level&quot; for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are calculated. The difference in course of &quot;Function level&quot;, between the rituximab and placebo groups, constitute a secondary endpoint.&#xD;
Also, the differences between the rituximab and placebo groups, for changes in selfreported &quot;Fatigue score&quot; and in selfreported &quot;Function level&quot;, calculated from baseline to the mean value during the time interval 16-20 months, constitute secondary endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>24 months</time_frame>
    <description>Fatigue Severity Scale (FSS) is self-recorded at baseline and at 6, 12, 18, 24 months. The difference between the rituximab and placebo groups, in changes in FSS from baseline to 18 months follow-up, constitutes a secondary endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response duration</measure>
    <time_frame>During 24 months follow-up</time_frame>
    <description>Clinical response periods, defined as consecutive self-recorded Fatigue score at least 4.5 (scale 0-6) for a minimum of 8 weeks, during 24 months follow-up, are recorded.&#xD;
The difference in the longest consecutive clinical response period, between rituximab and placebo groups, constitutes a secondary endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained clinical response at 24 months</measure>
    <time_frame>Assessment at 24 months</time_frame>
    <description>The difference between rituximab and placebo groups, in fraction of patients with sustained clinical response (defined as Fatigue score of at least 4.5) at 24 months, constitute a secondary endpoint.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Toxicity and side-effects</measure>
    <time_frame>During 24 months follow-up</time_frame>
    <description>Toxicity and side effects will be recorded throughout 24 months follow-up, as specified in the protocol.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)</condition>
  <arm_group>
    <arm_group_label>Rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rituximab induction (two infusions two weeks apart) and maintenance (infusions at 3, 6, 9 and 12 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline (with added albumin), two infusions two weeks apart, followed by infusions at 3, 6, 9 and 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Induction with two infusions two weeks apart, rituximab 500 mg/m2 (max 1000 mg).&#xD;
Maintenance with rituximab infusions (500 mg fixed dose) at 3, 6, 9 and 12 months.</description>
    <arm_group_label>Rituximab</arm_group_label>
    <other_name>Rituxan</other_name>
    <other_name>Mabthera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline (NaCl 0,9%) added human albumin (Flexbumin) 0,4 mg/ml, two infusions two weeks apart. Maintenance infusions after 3,6, 9 and 12 months.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) according to&#xD;
             Canadian diagnostic criteria (Carruthers, 2003)&#xD;
&#xD;
          -  Duration of CFS/ME disease 2-15 years. For patients with mild CFS/ME duration of&#xD;
             disease must be 5-15 years.&#xD;
&#xD;
          -  Mild, Mild/Moderate, Moderate, Moderate/Severe and Severe CFS/ME may be included&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with fatigue, who do not comply with Canadian diagnostic criteria (2003)&#xD;
&#xD;
          -  Duration of CFS/ME &lt; 2 years or &gt;15 years&#xD;
&#xD;
          -  Patients with very severe CFS/ME&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Previous malignant disease (except basal cell carcinoma in skin or uterine cervical&#xD;
             dysplasia)&#xD;
&#xD;
          -  Previous treatment with B-lymphocyte depleting therapeutic monoclonal antibodies, such&#xD;
             as rituximab&#xD;
&#xD;
          -  Previous long-term systemic immunosuppressive treatment, including drugs such as&#xD;
             cyclosporine, azathioprine, mycophenolate mofetil, but except steroid treatment e.g.&#xD;
             for obstructive lung disease or for other autoimmune diseases such as ulcerative&#xD;
             colitis&#xD;
&#xD;
          -  Severe endogenous depression&#xD;
&#xD;
          -  Lack of ability to adhere to protocol&#xD;
&#xD;
          -  Known multi-allergy with clinically assessed risk from rituximab infusion&#xD;
&#xD;
          -  Reduced kidney function (serum creatinine &gt; 1,5x upper normal level)&#xD;
&#xD;
          -  Reduced liver function (serum bilirubin or transaminases &gt; 1,5x upper normal level)&#xD;
&#xD;
          -  Known HIV positivity, previous hepatitis B or hepatitis C&#xD;
&#xD;
          -  Evidence of ongoing, active and clinically relevant infection&#xD;
&#xD;
          -  Known immunodeficiency with risk from therapeutic B-cell depletion, such as&#xD;
             hypogammaglobulinemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olav Mella, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Oncology, Haukeland University Hospital, Bergen, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Oncology, Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>N-5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Notodden Hospital</name>
      <address>
        <city>Notodden</city>
        <zip>N-3675</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CFS/ME centre, Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>N-0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Rehabilitation Services, University Hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <zip>N-9038</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Pain and Complex Disorders, St. Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>N-7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <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>
  <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>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Fatigue Syndrome (CFS)</keyword>
  <keyword>Myalgic Encephalitis (ME)</keyword>
  <keyword>Rituximab</keyword>
  <keyword>B-lymphocyte depletion</keyword>
  <keyword>B-cell depletion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</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/NCT02229942
org study id: KTS-6-2014
secondary id: 2014-000795-25
secondary id: 229035
nct id: NCT02229942
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic
      Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from
      B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and
      maintenance treatment.
We have published a case series of pilot patient observations with B-cell depletion in
      Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) (Fluge and Mella, BMC Neurol,
      2009). Subsequently, we published a small randomized and double-blind phase II study using
      rituximab induction two infusions two weeks apart (Fluge et al, Plos One, 2011).

      We have completed an open label phase II study with 29 patients using rituximab induction and
      maintenance treatment (six rituximab infusions over 15 months, with follow-up for three
      years, unpublished).

      We hypothesize that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic
      Encephalopathy (CFS/ME) have a chronically activated immune system involving B-lymphocytes,
      possibly a variant of an autoimmune disease, and that patients may benefit from B-cell
      depletion therapy.

      Three substudies will be performed:

      Endothelial function: assessment of Flow-Mediated Dilation and skin microcirculation at
      baseline and repeated during the time interval 17-21 months.

      Cardiopulmonary exercise test for two following days: assessment at baseline and repeated
      during the time interval 17-21 months.

      Gastrointestinal function: assessment at baseline and repeated during the time interval 17-21
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fatigue score, selfreported.
time frame: Course of Fatigue score during 24 months follow-up.
description: Selfreported Fatigue score is registered every second week, as the mean score for the four symptoms: "Post-exertional malaise", "Fatigue", "Need for rest", "Daily functioning" (scale 0-6). Mean Fatigue scores for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are recorded for each patient. These data are used for statistical analysis. The difference in course of Fatigue score during 24 months follow-up, between the rituximab and placebo groups, will constitute the primary endpoint.
Overall response is recorded as the effect on CFS/ME symptoms during 24 months follow-up. The overall response is not predefined to a specific time interval, but is defined as mean Fatigue score at least 4.5 for at least 8 consecutive weeks for moderate response, and mean Fatigue score at least 5.0 for at least 8 consecutive weeks for major response. Single response periods and the sum of response periods during 24 months follow-up will be recorded.
measure: Short Form-36 (SF-36)
time frame: Changes in SF-36 scores during 24 months follow-up
description: SF-36 (ver 1.2) are selfreported by patients at baseline, and at 3, 6, 9, 12, 15, 18, 21 and 24 months follow-up. Changes in Physical health summary score, Physical function, and "Mean of five subdimensions" (Physical function, Bodily pain, Vitality, Social function, General health) are recorded. The difference in course during 24 months follow-up, between the rituximab and placebo groups, will constitute secondary endpoints.
Also, the difference between rituximab and placebo groups, in changes from baseline to recording at 18 months, for Physical health summary score, Physical function, and "mean of five SF-36 subdimensions", constitute secondary endpoints.
measure: Physical activity (Sensewear armband)
time frame: Analyzed at baseline and at interval 17-21 months
description: The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 17-21 months follow-up. Changes from baseline to analysis during the time interval 17-21 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. The difference between rituximab and placebo groups will constitute secondary endpoints.
measure: Self-recorded "Function level"
time frame: Course during 24 months follow-up
description: Self-recorded "Function level" (scale 0-100, compared to healthy state, according to a set of examples) are registered every second week. Mean "Function level" for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are calculated. The difference in course of "Function level", between the rituximab and placebo groups, constitute a secondary endpoint.
Also, the differences between the rituximab and placebo groups, for changes in selfreported "Fatigue score" and in selfreported "Function level", calculated from baseline to the mean value during the time interval 16-20 months, constitute secondary endpoints.
measure: Fatigue Severity Scale
time frame: 24 months
description: Fatigue Severity Scale (FSS) is self-recorded at baseline and at 6, 12, 18, 24 months. The difference between the rituximab and placebo groups, in changes in FSS from baseline to 18 months follow-up, constitutes a secondary endpoint.
measure: Clinical response duration
time frame: During 24 months follow-up
description: Clinical response periods, defined as consecutive self-recorded Fatigue score at least 4.5 (scale 0-6) for a minimum of 8 weeks, during 24 months follow-up, are recorded.
The difference in the longest consecutive clinical response period, between rituximab and placebo groups, constitutes a secondary endpoint.
measure: Sustained clinical response at 24 months
time frame: Assessment at 24 months
description: The difference between rituximab and placebo groups, in fraction of patients with sustained clinical response (defined as Fatigue score of at least 4.5) at 24 months, constitute a secondary endpoint.
measure: Toxicity and side-effects
time frame: During 24 months follow-up
description: Toxicity and side effects will be recorded throughout 24 months follow-up, as specified in the protocol.
arm group label: Rituximab
arm group type: Experimental
description: Rituximab induction (two infusions two weeks apart) and maintenance (infusions at 3, 6, 9 and 12 months)
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline (with added albumin), two infusions two weeks apart, followed by infusions at 3, 6, 9 and 12 months.
intervention type: Drug
intervention name: Rituximab
description: Induction with two infusions two weeks apart, rituximab 500 mg/m2 (max 1000 mg).
Maintenance with rituximab infusions (500 mg fixed dose) at 3, 6, 9 and 12 months.
arm group label: Rituximab
other name: Rituxan
other name: Mabthera
intervention type: Drug
intervention name: Placebo
description: Saline (NaCl 0,9%) added human albumin (Flexbumin) 0,4 mg/ml, two infusions two weeks apart. Maintenance infusions after 3,6, 9 and 12 months.
arm group label: Placebo
other name: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Olav Mella, MD, PhD
role: Principal Investigator
affiliation: Dept. of Oncology, Haukeland University Hospital, Bergen, Norway
facility: 
facility: 
facility: 
facility: 
facility: 
country: Norway
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
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
responsible party type: Sponsor
mesh term: Fatigue Syndrome, Chronic
mesh term: Myalgia
mesh term: Brain Diseases
mesh term: Encephalitis
mesh term: Syndrome
mesh term: Fatigue
mesh term: Rituximab