Clinical trial NCT01730495: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Keywords: Chronic fatigue syndrome
CFS
Myalgic Encephalomyelitis (ME)
CFS/ME
Tumor necrosis factor-alpha
TNF-alpha
Etanercept
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
timeFrame: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
Secondary outcomes:
measure: Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
timeFrame: At 3, 6, 9, 12 months after start of intervention.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway
Study officials:
affiliation: Dept. of Oncology and Medical Physics, Haukeland University Hospital
name: Øystein Fluge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.