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NCT00848692 Clinical Trial

Drug Intervention in Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00848692
Other study ID # 18257
Secondary ID EudraCT: 2007-00
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2008
Est. completion date June 2010

Study information
Verified date June 2011
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
• Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart

Locations
Country Name City State
Norway Department of Oncology and Medical Physics, Haukeland University Hospital Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. 3 months after intervention
Secondary 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
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