http://www.hegerenate.com/
Fluge en Mella gaan onderzoeken in hoeverre
Etanercept, een TNFa-remmer, werkzaam is
bij ME/CVS-patiënten, mede als alternatief voor patiënten die niet reageren op Rituximab.
Patiënten 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, én
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
|
