Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
|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
|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|
|Primary Completion Date :||August 2014|
|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.
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|