Difference in Efficacy of Natalizumab Versus Fingolimod for the Treatment of Multiple Sclerosis
Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: biological samples and clinical data (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s): David Brassat, MD,PHD, Principal Investigator, Affiliation: U H Toulouse
Overall contact: David Brassat, MD, PHD, Phone: 5 61 77 20 67, Ext: 33, Email: brassat.d@chu-toulouse.fr
Summary
Under the escalation treatment strategy when a patient displays breakthrough disease
parameters under first line therapy, MS physicians are allowed by the EMEA to switch for
Natalizumab (NTZ) or fingolimod (FGL). NTZ and FGL efficacy have been demonstrated by
randomized therapeutic trial. As both treatments have been tested versus placebo a common
way to compare them is to look at their respective annualized relapse risk ratio decrease.
Roughly NTZ decrease by 70% and FGL by 50%. Nevertheless it is a terrible comparison since
the placebo group had different behaviour in the 2 trials and the patients demographic
features at baseline are also different. Therefore, it is right now totally impossible to
compare these 2 drugs with a decent methodology. Only a head-to-head comparison could do it.
Unfortunately this head-to-head comparison is not available and will not probably be done
under the drug companies initiative. During the time of this study, we will perform a phase
IV, observational, prospective head-to-head comparison of NTZ versus FGL efficacy in 600
patients. Our primary end point will be disease free patients after 1 year of treatment.
Further, this trial will allow us to collect new biological samples, useful for a validation
our project main aim. Further these new samples will be obtained from 3 European countries,
which is a must if we want to generalize our conclusion obtained from a French cohort.
Cooperation at the European level is thus essential for the implementation of this project .
Clinical Details
Official title: Essai de Phase IV, Multicentrique, Ouvert, Visant à Tester la différence d'efficacité du Natalizumab, Versus le Fingolimod, 2 médicaments Ayant Une AMM Pour le Traitement de la sclérose en Plaques
Study design: Time Perspective: Prospective
Primary outcome: Disease free patients
Secondary outcome: comparing the efficacy of Natalizumab with that of Fingolimod with regard to the annual incidence rate (comparison against the annual incidence rate criterion after 1 year
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diagnosis of relapsing-remitting MS in line with McDonald criteria;
- patient needing to be treated with FGL or NTZ, either:
- Patients who have not responded to complete and well-conducted treatment with
beta interferon. The patients should have presented at least one relapse during
the course of the previous year while they were receiving treatment, and should
present at least 9 hyper-intense lesions within T2 on a cerebral MRI, or at
least 1 enhancing lesion following injection of Gadolinium; or
- Patients presenting severe and rapidly developing relapsing-remitting multiple
sclerosis, defined by 2 debilitating relapses or more during the course of one
year, combined with 1 or more high-intensity lesion(s) following injection of
Gadolinium on a cerebral MRI, or a significant increase in lesion load within T2
compared to a recent prior MRI.
- EDSS score between 0 and 6, not inclusive;
- patient who give informed consent, and signed the consent form;
- patient available for 12-month follow-up.
Exclusion Criteria:
- General exclusion criteria: The patient is subject to judicial protection,
supervision or guardianship, the patient is pregnant, is about to give birth, or is
breast-feeding, or there is an existing medical or major psychiatric condition that,
in the investigator's opinion, could represent a risk for the subject or could
compromise compliance with the study protocol.
- Contraindication to the use of NTZ and FGL in line with the marketing authorisation:
for NTZ, the risk of tuberculosis assessed by means of intracutaneous reaction or
quantiferon dosage, for FGL, positive VZV serology and an absence of risk factors for
bradycardia and heart rate problems, and for both molecules, an absence of biological
signs suggesting immunodepression (negative HIV serology, normal CD3, CD4, CD8 and
CD19 levels, weight-adjusted dosage of immunoglobulin normal).
- prior treatment with FGL or NTZ;
- prior treatment with Mitoxantrone or Cyclophosphamide type immunosuppressants during
the 5 years before inclusion.
Locations and Contacts
David Brassat, MD, PHD, Phone: 5 61 77 20 67, Ext: 33, Email: brassat.d@chu-toulouse.fr
CHU Jean Minjoz, Besancon 25000, France; Not yet recruiting Eric Berger, MD, Email: lrumbach@chu-besancon.fr Eric Berger, MD, Principal Investigator
CHU bordeaux, Bordeaux 33 000, France; Not yet recruiting Bruno Brochet, MD PHD, Email: bruno.brochet@chu-bordeaux.fr bruno brochet, MD PHD, Principal Investigator
CHU de Caen, Caen 14033, France; Not yet recruiting Gilles-Louis Defer, MD PHD, Email: defer-gi@chu-caen.fr Gilles-Louis Defer, MD PHD, Principal Investigator
Chu Roger Salengro, Lille 59037, France; Not yet recruiting Patrick Vermersch, MD PHD Patrick Vermersch, MD PHD, Principal Investigator
Chu La Timone, Marseille 13385, France; Not yet recruiting Jean Pelletier, MD PHD Jean Pelletier, MD PHD, Principal Investigator
CHU Nancy, Nancy 54035, France; Not yet recruiting Marc Debouverie, MD PHD Marc Debouverie, MD PHD, Principal Investigator
CHU Nantes, Nantes 44093, France; Recruiting David Laplaud, MD, Email: david.laplaud@chu-nantes.fr David Laplaud, MD, Principal Investigator
Chu Pasteur, Nice 06002, France; Not yet recruiting Christine Lebrun-Frenay, MD Christine Lebrun-Frenay, MD, Principal Investigator
CHU Montpellier-Nîmes, Nimes 30029, France; Not yet recruiting Pierre Labauge, MD PHD Labauge Pierre, MD PHD, Principal Investigator
CHRU Strasbourg, Strasbourg 67098, France; Not yet recruiting Jérôme De Seze, MD pHD Jerome De Seze, MD PHD, Principal Investigator
Université de Muenter, Munster, Germany; Not yet recruiting H Wiendl, MD PHD H Wiendl, MD PHD, Principal Investigator
Hôpital Vall D'Hebron, Barcelone, Spain; Not yet recruiting Xavier Montalban, MD PHD XAVIER Montalban, MD PHD, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: April 24, 2015
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