Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
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
|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.|
- 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.
- 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:||October 2012|
|Estimated Study Completion Date:||April 2015|
|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.
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|
|Principal Investigator:||Øystein Fluge, MD, PhD||Dept. of Oncology and Medical Physics, Haukeland University Hospital|