Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01730495 : Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
PhasePhase 2
AgesMin: 18 Years Max: 66 Years
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, mycophenolatemofetil, 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.
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