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Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome

Kati

Patient in training
Messages
5,497
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.
 

Kati

Patient in training
Messages
5,497
I agree, SOC, this is exactly what we need. Real clinical trials. It is unclear to me who exactly is funding the trial, whether Haukland University /Hospilal is footing the bill. Enbrel is not exactly cheap as far as I know.
 

ukxmrv

Senior Member
Messages
4,413
Location
London
This is the sort of work that Dr Kerr wanted to do in the UK years ago. However, the MRC would not fund him and the hospital he worked at got rid of his clinic and him. Such a waste of so many years.

Thank you Dr Mella and Dr Fluge !
 

baccarat

Senior Member
Messages
188
Studies like this are helpful primarily because they add to the evidence that ME is a biological illness.
Treatment-wise not very, as I'd be surprised one can treat ME by downregulating one of the so many immune imbalances but may be it can help suppress some symptoms.
In terms of costs one needn't spend money on any drug as there are many herbals that modulate TNF quite effectively Studies on helpful herbals can be pulled with a simple search.
 

ukxmrv

Senior Member
Messages
4,413
Location
London
Baccarat, I belonged to another group who were using anti-TNF drugs. We did try the herbs but regular testing of that group didn't show that the herbs and supplements were effective.
 

baccarat

Senior Member
Messages
188
Hi ukxmrv, yes it's possible that some herbals don't work well. A lot of herbals are organ specific so one also needs to look at what symptoms/organs are mostly involved. Most have been studied in a test tube only and that doesn't tell a lot. For e.g. silymarin is considered an effective TNF modulator and it's one of the herbs used a lot in germany for Lyme where TNF is an issue but it didn't work very well for me, perhaps because it goes mainly to the liver. Curcumin is another potentially good but absorption is poor. Nettle leaf is good for arthritis but raises my histamine levels too much. So I find that with herbs we need to check many aspects.
 

ramakentesh

Senior Member
Messages
534
They are using anti TNF alpha because as a 'proof of concept' that excessive elaboration of TNF alpha is the primary problem in some CFS patients. Since I also have Ankylosing Spondylitis I have been offered Humira and Simponi in the past but I was cautious about taking them at this stage.
Will be very interested in how this goes.
Incidently my concern is that its actually interluekin (6, 1 and a few others) that are the big players in some CFS. They are certainly elevated in POTS.
 

ramakentesh

Senior Member
Messages
534
Many herbs are reputed to mildly inhibit TNF alpha. Psychedelic drugs like LSD and DOM do so more potently than any other substance know apparently! They have side effects though LOL.
 

Old Salt

Rowing the boat
Messages
70
Location
S/W Pa.
Many herbs are reputed to mildly inhibit TNF alpha. Psychedelic drugs like LSD and DOM do so more potently than any other substance know apparently! They have side effects though LOL.
It is said, a digestive enzyme protcol and Virastop are useful in controling CFS and autism. Any knowledge here?