Kati
Patient in training
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Dr Mella and Dr Fluge started Embrel study in Norway!
http://clinicaltrial.gov/ct2/show/NCT01730495?term=Chronic+fatigue+syndrome&rank=2
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
Purpose: 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.
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.
Primary Outcome Measures:
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.
Secondary Outcome Measures:
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.
Eligibility
Ages Eligible for Study: 18 Years to 66 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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, mycophenolatemofetil, 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.
http://clinicaltrial.gov/ct2/show/NCT01730495?term=Chronic+fatigue+syndrome&rank=2
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
Purpose: 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.
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.
Primary Outcome Measures:
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.
Secondary Outcome Measures:
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.
Eligibility
Ages Eligible for Study: 18 Years to 66 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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, mycophenolatemofetil, 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.