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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
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : October 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Norway
Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway
Bergen, Norway, N-5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Øystein Fluge, MD, PhD Dept. of Oncology and Medical Physics, Haukeland University Hospital
More Information
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Publications:

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01730495    
Other Study ID Numbers: 2011/2500
2011-006069-16 ( EudraCT Number )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Haukeland University Hospital:
Chronic fatigue syndrome
CFS
Myalgic Encephalomyelitis (ME)
CFS/ME
 Tumor necrosis factor-alpha
TNF-alpha
Etanercept
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Encephalomyelitis
Myalgia
Syndrome
Fatigue
Necrosis
Disease
Pathologic Processes
Virus Diseases
Infections
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
 Central Nervous System Infections
Musculoskeletal Pain
Pain
Neurologic Manifestations
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents