1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Phoenix Rising Adds Two New Board Members
Mark Berry introduces the new President of Phoenix Rising, Dr. Gary Solomon, and welcomes Professor Jonathan Edwards to the Phoenix Rising Board of Directors.
Discuss the article on the Forums.

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

Discussion in 'Active Clinical Studies' started by Kati, Apr 1, 2013.

  1. Kati

    Kati Patient in training

    Messages:
    1,959
    Likes:
    1,268
    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.
    NK17, redrachel76, Valentijn and 3 others like this.
  2. SOC

    SOC Moderator and Senior Member

    Messages:
    5,286
    Likes:
    6,275
    USA
    Hurray! This is the kind of research that could make important strides in ME/CFS treatment. Three cheers for Drs Melle and Fluge! :balloons:
    merylg, ukxmrv and Kati like this.
  3. Kati

    Kati Patient in training

    Messages:
    1,959
    Likes:
    1,268
    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.
    merylg likes this.
  4. ukxmrv

    ukxmrv Senior Member

    Messages:
    3,422
    Likes:
    1,912
    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 !
    NK17 and Kati like this.
  5. Kati

    Kati Patient in training

    Messages:
    1,959
    Likes:
    1,268
    Dr Kerr's story,whatever it is, is a sad one. Such a brilliant mind that has been silenced, somehow.
    NK17 and ukxmrv like this.
  6. baccarat

    baccarat Senior Member

    Messages:
    188
    Likes:
    80
    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.
  7. ukxmrv

    ukxmrv Senior Member

    Messages:
    3,422
    Likes:
    1,912
    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.
  8. baccarat

    baccarat Senior Member

    Messages:
    188
    Likes:
    80
    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.
  9. adreno

    adreno 3% neanderthal

    Messages:
    2,310
    Likes:
    1,442
    Tundras of Europa
    Glutathione inhibits TNF-alpha.
  10. ramakentesh

    ramakentesh Senior Member

    Messages:
    525
    Likes:
    81
    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.
  11. ramakentesh

    ramakentesh Senior Member

    Messages:
    525
    Likes:
    81
    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.
  12. Old Salt

    Old Salt Rowing the boat

    Messages:
    70
    Likes:
    19
    S/W Pa.
    It is said, a digestive enzyme protcol and Virastop are useful in controling CFS and autism. Any knowledge here?
  13. Starfive

    Starfive

    Messages:
    65
    Likes:
    36
    ramakentesh Can you share your source for your comment about Psychedelics? Thanks.
  14. heapsreal

    heapsreal iherb 10% discount code OPA989,

    Messages:
    7,214
    Likes:
    4,508
    australia (brisbane)
    Is there any updates on this study??
    NK17 and Kati like this.

See more popular forum discussions.

Share This Page