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Drug Intervention in Chronic Fatigue Syndrome (KTS-1-2008)

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ClinicalTrials.gov Identifier: NCT00848692
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
Haukeland University Hospital

Study Description
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Brief Summary:

Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.

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.


Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Drug: Rituximab Drug: Saline (NaCl 0,9 %) (placebo) Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
Study Start Date : June 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Rituximab
 Drug: Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
Placebo Comparator: 2
Placebo (saline)
 Drug: Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart


Outcome Measures
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Primary Outcome Measures :
  1. Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 3 months after intervention ]

Secondary Outcome Measures :
  1. Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes [ Time Frame: 2, 4, 6, 8, 10, 12 months after intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • verified chronic fatigue syndrome (CDC-criteria)
  • age >18 and <60 years
  • informed consent

Exclusion Criteria:

  • pregnancy or lactation
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848692


Locations
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Norway
Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, Norway, N-5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Olav Mella, MD, PhD Department of Oncology and Medical Physics, Haukeland University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Olav Mella, Professor, Department Director, Department of Oncology and Medical Physics, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00848692    
Other Study ID Numbers: 18257
EudraCT: 2007-007973-22
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011
Keywords provided by Haukeland University Hospital:
Chronic Fatigue Syndrome
CFS
Myalgic Encephalomyelitis
 Rituximab
B-lymphocyte depletion
B-cell depletion
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
 Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents