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

Study Overview
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Brief Summary
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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.

Official Title
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Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no Clinical Response After B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab.

Conditions
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Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

Intervention / Treatment
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* Drug: Etanercept


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept<br> | Drug: Etanercept<br>* Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes. | The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded. | Response of at least six weeks duration, independent on when occuring, during 12 months follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. | The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention. | At 3, 6, 9, 12 months after start of intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept