Overview

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