Clinical Trial: B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. An Open Label Phase II Study With Rituximab Induction and Maintenance Treatment
Brief Summary:
Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.
The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that prolonged 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: Major response of at least six weeks duration, independent on when occuring, during the follow-up period. ]
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: At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention ]
Original Secondary Outcome: Same as current
Information By: Haukeland University Hospital
Dates:
Date Received: July 2, 2010
Date Started: October 2010
Date Completion:
Last Updated: August 29, 2014
Last Verified: August 2014