Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00848692
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE February 19, 2009
First Posted Date  ICMJE February 20, 2009
Last Update Posted Date May 11, 2021
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 3 months after intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Intervention in Chronic Fatigue Syndrome
Official Title  ICMJE B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Fatigue Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Rituximab
    Intervention: Drug: Rituximab
  • Placebo Comparator: 2
    Placebo (saline)
    Intervention: Drug: Saline (NaCl 0,9 %) (placebo)
Publications * 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. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00848692
Other Study ID Numbers  ICMJE 18257
EudraCT: 2007-007973-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olav Mella, MD, PhD Department of Oncology and Medical Physics, Haukeland University Hospital
PRS Account Haukeland University Hospital
Verification Date June 2011

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