Drug Intervention in Chronic Fatigue Syndrome

B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.

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.

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