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

Sponsor

Haukeland University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01730495

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome Myalgic Encephalomyelitis	Drug: Etanercept	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etanercept	Drug: Etanercept Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.

Arm

Intervention/Treatment

Experimental: Etanercept

Drug: Etanercept

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 66 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.