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

Phase 2

Terminated

• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
• Interventions: Drug: Etanercept

• Registration Number: NCT01730495
• Lead Sponsor: Haukeland University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etanercept	Etanercept	-

Primary Outcome Measures

Name	Time	Method
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.	Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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