Trial record 1 of 67 for:
"Chronic Fatigue Syndrome"
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)
Information provided by (Responsible Party):
Haukeland University Hospital
First received: November 8, 2012
Last updated: August 29, 2014
Last verified: August 2014
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.
Chronic Fatigue Syndrome
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
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.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2015 (Final data collection date for primary outcome measure)
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
|Ages Eligible for Study:
||18 Years to 66 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01730495
|Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway
|Bergen, Norway, N-5021 |
Haukeland University Hospital
||Øystein Fluge, MD, PhD
||Dept. of Oncology and Medical Physics, Haukeland University Hospital
||Haukeland University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 8, 2012
||August 29, 2014
||Norway: Directorate of Health
Norway: Norwegian Medicines Agency
Keywords provided by Haukeland University Hospital:
Chronic fatigue syndrome
Myalgic Encephalomyelitis (ME)
Tumor necrosis factor-alpha
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 15, 2014
Fatigue Syndrome, Chronic
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Signs and Symptoms
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs