NCT00848692

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
DRUG	Rituximab	Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
DRUG	Saline (NaCl 0,9 %) (placebo)	Two infusions of saline (NaCl 0,9 %) given two weeks apart

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-02-20
• Last updated: 2021-05-11

Locations

1 site across 1 country: Norway