Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2008-06-30
2010-06-30
Brief Summary
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The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Rituximab
Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
2
Placebo (saline)
Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart
Interventions
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Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart
Eligibility Criteria
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Inclusion Criteria
* age \>18 and \<60 years
* informed consent
Exclusion Criteria
* previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
* previous long-term use of immunosuppressive drugs
* previous exposure to rituximab
* endogenous depression
* multi-allergy with risk of serious drug reaction
* reduced renal function (creatinin \> 1.2 x UNL)
* reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
* known HIV infection
* signs of active viral infection by pretreatment investigations
18 Years
60 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Olav Mella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology and Medical Physics, Haukeland University Hospital
Locations
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Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, , Norway
Countries
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References
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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.
Other Identifiers
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EudraCT: 2007-007973-22
Identifier Type: -
Identifier Source: secondary_id
18257
Identifier Type: -
Identifier Source: org_study_id
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