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

This study has been terminated.
(After inclusion of four patients, two experienced moderate worsening of symptoms)
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01730495
First received: November 8, 2012
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Drug: Etanercept
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: At 3, 6, 9, 12 months after start of intervention. ] [ Designated as safety issue: Yes ]
    The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.


Enrollment: 4
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept Drug: Etanercept
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730495

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

Publications:
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01730495     History of Changes
Other Study ID Numbers: 2011/2500, 2011-006069-16
Study First Received: November 8, 2012
Last Updated: August 29, 2014
Health Authority: Norway: Directorate of Health
Norway: Norwegian Medicines Agency

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:
Fatigue
Fatigue Syndrome, Chronic
Syndrome
Necrosis
Encephalomyelitis
Myalgia
Signs and Symptoms
Pathologic Processes
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Disease
Encephalitis
Brain Diseases
Central Nervous System Infections
Musculoskeletal Pain
Pain
Neurologic Manifestations
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 16, 2014