Clinical Trial: Drug Intervention in Chronic Fatigue Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
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.
Detailed Summary:
Sponsor: Haukeland University Hospital
Current Primary Outcome: Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 3 months after intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Haukeland University Hospital
Dates:
Date Received: February 19, 2009
Date Started: June 2008
Date Completion:
Last Updated: June 1, 2011
Last Verified: June 2011
