Difference in Efficacy of Natalizumab Versus Fingolimod for the Treatment of Multiple Sclerosis (BEST-MS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01981161
First received: November 4, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 .


Condition Phase
Multiple Sclerosis
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Disease free patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

urine and blood


Estimated Enrollment: 600
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fingolimod
patients treated by Fingolimod
Natalizumab
patients treated by Natalizumab

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Multiple sclerosis

Criteria

Inclusion Criteria:

  1. patients aged between 18 and 55;
  2. diagnosis of relapsing-remitting MS in line with McDonald criteria;
  3. 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.
  4. EDSS score between 0 and 6, not inclusive;
  5. patient who has given his/her free and informed consent, and signed the consent form;
  6. patient who is a member or beneficiary of a sickness insurance scheme;
  7. patient available for 12-month follow-up.

Exclusion Criteria:

  1. 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.
  2. 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).
  3. prior treatment with FGL or NTZ;
  4. prior treatment with Mitoxantrone or Cyclophosphamide type immunosuppressants during the 5 years before inclusion.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981161

Contacts
Contact: David Brassat, MD, PHD 33 561 77 20 67 brassat.d@chu-toulouse.fr
Contact: Delphine VERNET 0561777216 vernet.d@chu-toulouse.fr

Locations
France
CHU Jean Minjoz Not yet recruiting
Besancon, France, 25000
Contact: Eric Berger, MD       lrumbach@chu-besancon.fr   
Principal Investigator: Eric Berger, MD         
CHU bordeaux Not yet recruiting
Bordeaux, France, 33 000
Contact: Bruno Brochet, MD PHD       bruno.brochet@chu-bordeaux.fr   
Principal Investigator: bruno brochet, MD PHD         
CHU de Caen Not yet recruiting
Caen, France, 14033
Contact: Gilles-Louis Defer, MD PHD       defer-gi@chu-caen.fr   
Principal Investigator: Gilles-Louis Defer, MD PHD         
Chu Roger Salengro Not yet recruiting
Lille, France, 59037
Contact: Patrick Vermersch, MD PHD         
Principal Investigator: Patrick Vermersch, MD PHD         
Chu La Timone Not yet recruiting
Marseille, France, 13385
Contact: Jean Pelletier, MD PHD         
Principal Investigator: Jean Pelletier, MD PHD         
CHU Nancy Not yet recruiting
Nancy, France, 54035
Contact: Marc Debouverie, MD PHD         
Principal Investigator: Marc Debouverie, MD PHD         
CHU Nantes Recruiting
Nantes, France, 44093
Contact: David Laplaud, MD       david.laplaud@chu-nantes.fr   
Principal Investigator: David Laplaud, MD         
Chu Pasteur Not yet recruiting
Nice, France, 06002
Contact: Christine Lebrun-Frenay, MD         
Principal Investigator: Christine Lebrun-Frenay, MD         
CHU Montpellier-Nîmes Not yet recruiting
Nimes, France, 30029
Contact: Pierre Labauge, MD PHD         
Principal Investigator: Labauge Pierre, MD PHD         
CHRU Strasbourg Not yet recruiting
Strasbourg, France, 67098
Contact: Jérôme De Seze, MD pHD         
Principal Investigator: Jerome De Seze, MD PHD         
Germany
Université de Muenter Not yet recruiting
Munster, Germany
Contact: H Wiendl, MD PHD         
Principal Investigator: H Wiendl, MD PHD         
Spain
Hôpital Vall D'Hebron Not yet recruiting
Barcelone, Spain
Contact: Xavier Montalban, MD PHD         
Principal Investigator: XAVIER Montalban, MD PHD         
Sponsors and Collaborators
University Hospital, Toulouse
European Commission
Investigators
Principal Investigator: David Brassat, MD,PHD U H Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01981161     History of Changes
Other Study ID Numbers: 1235207
Study First Received: November 4, 2013
Last Updated: July 22, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
progressive multifocal leucoencephalopathy
JC virus
Zoster infection

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014