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

This study has been completed.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00848692
First received: February 19, 2009
Last updated: June 1, 2011
Last verified: June 2011
History of Changes

February 19, 2009
June 1, 2011
June 2008
June 2010   (final data collection date for primary outcome measure)
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 3 months after intervention ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00848692 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug Intervention in Chronic Fatigue Syndrome
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Fatigue Syndrome
  • Drug: Rituximab
    Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
  • Drug: Saline (NaCl 0,9 %) (placebo)
    Two infusions of saline (NaCl 0,9 %) given two weeks apart
  • Experimental: 1
    Rituximab
    Intervention: Drug: Rituximab
  • Placebo Comparator: 2
    Placebo (saline)
    Intervention: Drug: Saline (NaCl 0,9 %) (placebo)
Fluge Ø, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Næss 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. Epub 2011 Oct 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00848692
18257, EudraCT: 2007-007973-22
No
Olav Mella, Professor, Department Director, Department of Oncology and Medical Physics, Haukeland University Hospital
Haukeland University Hospital
Not Provided
Principal Investigator: Olav Mella, MD, PhD Department of Oncology and Medical Physics, Haukeland University Hospital
Haukeland University Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP