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

This study has been completed.
Information provided by:
Haukeland University Hospital Identifier:
First received: February 19, 2009
Last updated: June 1, 2011
Last verified: June 2011

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 Intervention Phase
Chronic Fatigue Syndrome
Drug: Rituximab
Drug: Saline (NaCl 0,9 %) (placebo)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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


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

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
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Please refer to this study by its identifier: NCT00848692

Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, Norway, N-5021
Sponsors and Collaborators
Haukeland University Hospital
Principal Investigator: Olav Mella, MD, PhD Department of Oncology and Medical Physics, Haukeland University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Olav Mella, Professor, Department Director, Department of Oncology and Medical Physics, Haukeland University Hospital Identifier: NCT00848692     History of Changes
Other Study ID Numbers: 18257
EudraCT: 2007-007973-22
Study First Received: February 19, 2009
Last Updated: June 1, 2011

Keywords provided by Haukeland University Hospital:
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
B-lymphocyte depletion
B-cell depletion

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 25, 2017