Drug Intervention in Chronic Fatigue Syndrome

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Rituximab

Criteria

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