Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome

Haukeland University Hospital

Status and phase

Terminated

Phase 2

Conditions

Myalgic Encephalomyelitis

Chronic Fatigue Syndrome

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Other

Identifiers

NCT01730495

2011-006069-16 (EudraCT Number)

2011/2500

Details and patient eligibility

About

The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.

Enrollment

4 patients

Sex

All

Ages

18 to 66 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
moderate and serious CFS/ME severity
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 long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease.
demyelinating disease, such as multiple sclerosis.
heart failure.
endogenous depression.
lack of ability to comply to the protocol.
multi-allergy with risk of serious drug reaction
reduced renal function (creatinine > 1.5 x UNL)
reduced liver function (bilirubin or transaminases > 1.5 x UNL)
HIV positivity. Evidence of clinically significant infection. Previous viral hepatitis with risk of reactivation. High risk of opportunistic infections. Latent tuberculosis must be treated before inclusion.