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OpenTrials
Completed

NCT Number: NCT00848692

Drug Intervention in Chronic Fatigue Syndrome

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.

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Oncology and Medical Physics, Haukeland University Hospital

Bergen, N-5021, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart

Saline (NaCl 0,9 %) (placebo)

Drug

Two infusions of saline (NaCl 0,9 %) given two weeks apart

Primary outcomes

  1. Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.

    Time frame: 3 months after intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.

Acronym: KTS-1-2008

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 20, 2009
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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