Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Conditions
Keywords
Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept
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.
Interventions
DRUGEtanercept
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
Sponsors
Haukeland University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. | 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. |
Countries
Norway
Outcome results
None listed