Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, 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
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01730495      |      Link to official Clinicaltrials.gov listing
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