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Drug Intervention in Chronic Fatigue Syndrome (KTS-1-2008)
This study has been completed.
Sponsor:
Haukeland University Hospital
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00848692
First received: February 19, 2009
Last updated: June 1, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Chronic Fatigue Syndrome | Drug: Rituximab Drug: Saline (NaCl 0,9 %) (placebo) | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study. |
Resource links provided by NLM:
Further study details as provided by Haukeland University Hospital:
Primary Outcome Measures:
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 3 months after intervention ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00848692
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848692
Locations
| Norway | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Olav Mella, Professor, Department Director, Department of Oncology and Medical Physics, Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT00848692 History of Changes |
| Other Study ID Numbers: |
18257 EudraCT: 2007-007973-22 |
| Study First Received: | February 19, 2009 |
| Last Updated: | June 1, 2011 |
Keywords provided by Haukeland University Hospital:
|
Chronic Fatigue Syndrome CFS Myalgic Encephalomyelitis |
Rituximab B-lymphocyte depletion B-cell depletion |
Additional relevant MeSH terms:
|
Syndrome Fatigue Fatigue Syndrome, Chronic Disease Pathologic Processes Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases |
Encephalomyelitis Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on August 17, 2017