Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
Primary Purpose
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept
Eligibility 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.
Sites / Locations
- Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etanercept
Arm Description
Outcomes
Primary Outcome Measures
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
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.
The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.
Full Information
NCT ID
NCT01730495
First Posted
November 8, 2012
Last Updated
November 30, 2015
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01730495
Brief Title
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
After inclusion of four patients, two experienced moderate worsening of symptoms
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Keywords
Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etanercept
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
Primary Outcome Measure Information:
Title
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
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.
Time Frame
Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
Secondary Outcome Measure Information:
Title
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Description
The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.
Time Frame
At 3, 6, 9, 12 months after start of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Fluge, MD, PhD
Organizational Affiliation
Dept. of Oncology and Medical Physics, Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22039471
Citation
Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.
Results Reference
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PubMed Identifier
19566965
Citation
Fluge O, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28.
Results Reference
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Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
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