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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Etanercept

Criteria

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.