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

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ClinicalTrials.gov Identifier: NCT01981161
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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 .

Condition or disease Intervention/treatment
Multiple Sclerosis Procedure: biological samples and clinical data

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Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Other
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
Actual Study Start Date : November 19, 2013
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : November 30, 2018


Group/Cohort Intervention/treatment
Fingolimod
patients treated by Fingolimod will have biological samples and clinical data
Procedure: biological samples and clinical data
Natalizumab
patients treated by Natalizumab will have biological samples and clinical data
Procedure: biological samples and clinical data



Primary Outcome Measures :
  1. Disease free patients [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
urine and blood


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple sclerosis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981161


Locations
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France
CHU Besançon
Besancon, France, 25000
CHU Bordeaux
Bordeaux, France, 33 000
CHU Caen
Caen, France, 14033
Chu Lille
Lille, France, 59037
Chu La Timone
Marseille, France, 13385
CHU Nancy
Nancy, France, 54035
CHU Nantes
Nantes, France, 44093
CHU Nice
Nice, France, 06002
CHU Nîmes
Nimes, France, 30029
CHRU Strasbourg
Strasbourg, France, 67098
Germany
Université de Muenter
Munster, Germany
Spain
Hôpital Vall D'Hebron
Barcelone, Spain
Sponsors and Collaborators
University Hospital, Toulouse
European Commission
Investigators
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Principal Investigator: David Brassat, MD,PHD U H Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01981161    
Other Study ID Numbers: 1235207
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Toulouse:
progressive multifocal leucoencephalopathy
JC virus
Zoster infection
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases