Drug Intervention in Chronic Fatigue Syndrome
KTS-1-2008
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMay 11, 2021
June 1, 2011
2 years
February 19, 2009
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
3 months after intervention
Secondary Outcomes (1)
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
2, 4, 6, 8, 10, 12 months after intervention
Study Arms (2)
1
EXPERIMENTALRituximab
2
PLACEBO COMPARATORPlacebo (saline)
Interventions
Eligibility Criteria
You may qualify if:
- verified chronic fatigue syndrome (CDC-criteria)
- age \>18 and \<60 years
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, N-5021, Norway
Related Publications (1)
Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess 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.
PMID: 22039471DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olav Mella, MD, PhD
Department of Oncology and Medical Physics, Haukeland University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 20, 2009
Study Start
June 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
May 11, 2021
Record last verified: 2011-06