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.
18 Years
66 Years
Both
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Trial Information
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.
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, mycophenolatemofetil, 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Outcome Description:
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.
Outcome Time Frame:
Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
Safety Issue:
Yes
Principal Investigator
Øystein Fluge, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Oncology and Medical Physics, Haukeland University Hospital
Authority:
Norway: Directorate of Health
Study ID:
2011/2500
NCT ID:
NCT01730495
Start Date:
October 2012
Completion Date:
April 2015
Related Keywords:
- Chronic Fatigue Syndrome
- Myalgic Encephalomyelitis
- Chronic fatigue syndrome
- CFS
- Myalgic Encephalomyelitis (ME)
- CFS/ME
- Tumor necrosis factor-alpha
- TNF-alpha
- Etanercept
- Encephalomyelitis
- Fatigue
- Fatigue Syndrome, Chronic
- Necrosis
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