B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Antibodies; Rituximab

Criteria

Inclusion Criteria:

• patients with CFS

• age 18-66 years

• informed consent

Exclusion Criteria:

• patients with fatigue, not fulfilling criteria for CFS

• pregnancy or lactation

• previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ

• previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis

• previous long-term use of immunosuppressive drugs, except steroids e.g. in obstructive lunge disease

• endogenous depression

• lack of ability to comply by the protocol

• multi-allergy with risk of serious drug reaction

• reduced renal function (creatinin > 1.5 x UNL)

• reduced liver function (bilirubin or transaminases > 1.5 x UNL)

• HIV positivity

• evidence of clinically significant infection