Drug Intervention in Chronic Fatigue Syndrome (KTS-1-2008)
Primary Purpose
Chronic Fatigue Syndrome
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Rituximab
Saline (NaCl 0,9 %) (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic Fatigue Syndrome, CFS, Myalgic Encephalomyelitis, Rituximab, B-lymphocyte depletion, B-cell depletion
Eligibility Criteria
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
Sites / Locations
- Department of Oncology and Medical Physics, Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Rituximab
Placebo (saline)
Outcomes
Primary Outcome Measures
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Secondary Outcome Measures
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
Full Information
NCT ID
NCT00848692
First Posted
February 19, 2009
Last Updated
May 10, 2021
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00848692
Brief Title
Drug Intervention in Chronic Fatigue Syndrome
Acronym
KTS-1-2008
Official Title
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
Chronic Fatigue Syndrome, CFS, Myalgic Encephalomyelitis, Rituximab, B-lymphocyte depletion, B-cell depletion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rituximab
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo (saline)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
Intervention Type
Drug
Intervention Name(s)
Saline (NaCl 0,9 %) (placebo)
Intervention Description
Two infusions of saline (NaCl 0,9 %) given two weeks apart
Primary Outcome Measure Information:
Title
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Mella, MD, PhD
Organizational Affiliation
Department of Oncology and Medical Physics, Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology and Medical Physics, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22039471
Citation
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.
Results Reference
derived
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Drug Intervention in Chronic Fatigue Syndrome
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