Drug Intervention in Chronic Fatigue Syndrome (KTS-1-2008)
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ClinicalTrials.gov Identifier: NCT00848692 |
Recruitment Status :
Completed
First Posted : February 20, 2009
Last Update Posted : June 2, 2011
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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 |
---|---|---|
Chronic Fatigue Syndrome | Drug: Rituximab Drug: Saline (NaCl 0,9 %) (placebo) | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
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. |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

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)
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Drug: Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart |
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 3 months after intervention ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848692
Norway | |
Department of Oncology and Medical Physics, Haukeland University Hospital | |
Bergen, Norway, N-5021 |
Principal Investigator: | Olav Mella, MD, PhD | Department of Oncology and Medical Physics, Haukeland University Hospital |
Responsible Party: | Olav Mella, Professor, Department Director, Department of Oncology and Medical Physics, Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00848692 |
Other Study ID Numbers: |
18257 EudraCT: 2007-007973-22 |
First Posted: | February 20, 2009 Key Record Dates |
Last Update Posted: | June 2, 2011 |
Last Verified: | June 2011 |
Chronic Fatigue Syndrome CFS Myalgic Encephalomyelitis |
Rituximab B-lymphocyte depletion B-cell depletion |
Fatigue Syndrome, Chronic Syndrome Fatigue Disease Pathologic Processes Virus Diseases Muscular Diseases Musculoskeletal Diseases Encephalomyelitis |
Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |