Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
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|ClinicalTrials.gov Identifier: NCT01730495|
Recruitment Status : Terminated (After inclusion of four patients, two experienced moderate worsening of symptoms)
First Posted : November 21, 2012
Last Update Posted : December 2, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome Myalgic Encephalomyelitis||Drug: Etanercept||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||October 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
- Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 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.
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years to 66 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
- moderate and serious CFS/ME severity
- age 18-66 years
- informed consent
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730495
|Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway|
|Bergen, Norway, N-5021|
|Principal Investigator:||Øystein Fluge, MD, PhD||Dept. of Oncology and Medical Physics, Haukeland University Hospital|
|Responsible Party:||Haukeland University Hospital|
|Other Study ID Numbers:||
2011-006069-16 ( EudraCT Number )
|First Posted:||November 21, 2012 Key Record Dates|
|Last Update Posted:||December 2, 2015|
|Last Verified:||November 2015|
Chronic fatigue syndrome
Myalgic Encephalomyelitis (ME)
Tumor necrosis factor-alpha
Fatigue Syndrome, Chronic
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs