Chronic Fatigue Syndrome | Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
Chronic Fatigue Syndrome research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Fatigue Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:EtanerceptWeekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2012
Completed Date: August 2014
Phase: Phase 2
Primary Outcome: Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Secondary Outcome: Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Study sponsors, principal investigator, and references
Principal Investigator: Øystein Fluge, MD, PhD
Lead Sponsor: Haukeland University Hospital
Fluge Ø, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Næss 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.