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

Phase 2TerminatedNCT01730495

Haukeland University Hospital4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Fatigue Syndrome Myalgic Encephalomyelitis

Interventions

EtanerceptDRUG

Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway

Bergen, Norway

Outcomes

Primary Outcomes

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.

Time frame: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.

Secondary Outcomes

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.

Time frame: At 3, 6, 9, 12 months after start of intervention.

Data from ClinicalTrials.gov

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