KTS-1-2008: Drug Intervention in Chronic Fatigue Syndrome
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Rituximab |
Drug: Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
|
Placebo Comparator: 2 Placebo (saline) |
Drug: Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart
|
Outcome Measures
Primary Outcome Measures
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [3 months after intervention]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
verified chronic fatigue syndrome (CDC-criteria)
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age >18 and <60 years
-
informed consent
Exclusion Criteria:
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pregnancy or lactation
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previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
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previous long-term use of immunosuppressive drugs
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previous exposure to rituximab
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endogenous depression
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multi-allergy with risk of serious drug reaction
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reduced renal function (creatinin > 1.2 x UNL)
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reduced liver function (bilirubin or transaminases > 1.5 x UNL)
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known HIV infection
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signs of active viral infection by pretreatment investigations
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Oncology and Medical Physics, Haukeland University Hospital | Bergen | Norway | N-5021 |
Sponsors and Collaborators
- Haukeland University Hospital
Investigators
- Principal Investigator: Olav Mella, MD, PhD, Department of Oncology and Medical Physics, Haukeland University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18257
- EudraCT: 2007-007973-22