Drug Intervention in Chronic Fatigue Syndrome

Haukeland University Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Fatigue Syndrome

Interventions

RituximabDRUG

Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart

Saline (NaCl 0,9 %) (placebo)DRUG

Two infusions of saline (NaCl 0,9 %) given two weeks apart

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Oncology and Medical Physics, Haukeland University Hospital

Bergen, Norway

Outcomes

Primary Outcomes

Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.

Time frame: 3 months after intervention

Secondary Outcomes

Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes

Time frame: 2, 4, 6, 8, 10, 12 months after intervention

Data from ClinicalTrials.gov

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