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Fluge en Mella

stellen onderzoek in

naar het effect van

Etanercept,

een TNFa-remmer. 

 

 

 

 


 

 

http://www.hegerenate.com/

 

 

Fluge en Mella gaan onderzoeken in hoeverre Etanercept, een TNFa-remmer, werkzaam is

bij ME/CVS-patiŽnten, mede als alternatief voor patiŽnten die niet reageren op Rituximab.

 

 

 

 

PatiŽnten krijgen maximaal 1 jaar wekelijks een subcutane (onderhuidse) injectie.

De totale studie gaat ongeveer twee-en-een-half jaar in beslag nemen.

 

 

 

bron:

http://pharmacologycorner.com/mechanism-of-action-indications-

and-adverse-effects-of-etanercept-infliximab-and-adalimumab/

 

 

Omdat TNFa betrokken is bij inflammatie en (Th1- en Th2-) immuunactivatie

(Th1-immuunactivatie: klik hier en hier, ťn Th2-immuunactivatie: klik hier en hier) en

ME/CVS herhaaldelijk in verband gebracht is met verhoogde concentraties TNFa,

zou het reduceren van TNFa (symptomatisch) respijt kunnen bieden.

 

Maar net als bij Ritiximab is de vraag: wat stimuleert de inflammatie/immuunactivatie?

Zolang de oorzaak niet weggenomen wordt/kan worden, zal het effect tijdelijk zijn.

 

 


 

 

 

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

 

 

This study is currently recruiting participants.

 

Verified November 2012

by Haukeland University Hospital

 

Sponsor:

 

Haukeland University Hospital

Information provided by (Responsible Party):

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT01730495

First received: November 8, 2012

Last updated: November 15, 2012

Last verified: November 2012

 

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.

 

...

 

Estimated Enrollment:

15

Study Start Date:

October 2012

Estimated Study Completion Date:

April 2015

Estimated Primary Completion Date:

April 2015 (Final data collection date for primary outcome measure)

 

...

 

 

Arms

Assigned Interventions

Experimental: Etanercept

Drug: Etanercept

Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.

 

...

 

 

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 lung 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/study/NCT01730495