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Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis (IPBio-SeP)

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ClinicalTrials.gov Identifier: NCT03552211
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
OFSEP (Observatoire Français de la Sclérose en Plaques)
SFSEP (Société Francophone de la Sclérose en Plaques)
MedDay Pharmaceuticals SA
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Background: High dose biotin is a therapeutic option for French progressive Multiple Sclerosis (MS) patients, without relapse for at least one year, since June 1, 2016. Despite the inflammatory activity of progressive forms of MS is known to be low, several publications mentioned clinical and/or radiological activity for biotin-treated patients.

Objectives:

  1. To determine if high dose biotin increase the clinical inflammatory activity of patients with a progressive form of MS.
  2. To compare the clinical characteristics of the relapses that occurred with biotin or not.
  3. To describe the characteristics of the patients with a clinical inflammatory activity with biotin.

Methods: This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat. The main judgment criterion is the annualized relapse rate (ARR) from the beginning of the biotin to the last evaluation available before the data extraction. A Student's t test will be used. A negative binomial modelling with relapses counting over a period of exposure and taking into account the inter and intra center variability will be used. The statistical tests will be adapted to the nature of the variables concerning the secondary judgment criteria.

Expected results: This French national study will provide a better knowledge of the inflammatory activity of the progressive forms of MS treated with high dose biotin. If an increased clinical inflammatory activity is highlighted with biotin a prospective study will be necessary to confirm the result before a specific information of the scientific community and the patients about this risk or even an amendment of prescription rules in order to secure the use of the product. On the contrary, the absence of increased risk of clinical inflammatory activity with biotin would help to reassure the prescriber and the patient about the innocuity of the treatment.


Condition or disease Intervention/treatment
Progressive Multiple Sclerosis Drug: biotin Other: propensity score

Detailed Description:
Investigators are going to recruit retrospectively all the patients treated with biotin since the product is available in France, in all French MS centers that agree to participate (maximum 30). They are going to collect through medical records, demographic data (as age, gender, MS center localization), but also data about the disease (as MS duration, primary progressive or secondary progressive MS), data about disability (with several Expanded Disability Status Scale -EDSS- scores at different time points) and data about treatments (as duration of biotin, existence of other concomitant disease-modifying therapy). For comparison, a control group without biotin is going also to be recruited from the European Database for Multiple Sclerosis (EDMUS). The same data as described above are going to be collected for the controls.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis
Estimated Study Start Date : May 30, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Biotin

Group/Cohort Intervention/treatment
Patients treated with biotin
This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat
Drug: biotin
This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat.

Control patients
This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat
Other: propensity score
This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat.




Primary Outcome Measures :
  1. Relapses with biotin [ Time Frame: at day 1 (through study completion, an average of 1 year) ]
    To determine if high dose biotin increases the clinical inflammatory activity of patients with a progressive form of MS using the annualized relapse rate (ARR) comparing to a control group


Secondary Outcome Measures :
  1. Clinical characteristics of the relapses with biotin [ Time Frame: at day 1 (through study completion, an average of 1 year) ]
    To compare the clinical characteristics of the relapses that occurred with biotin or not.

  2. Characteristics of patients with relapse with biotin [ Time Frame: at day 1 (through study completion, an average of 1 year) ]
    To describe the characteristics of the patients with a clinical inflammatory activity with biotin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Progressive forms of Multiple Sclerosis
Criteria

Inclusion Criteria:

  • For the patients treated with biotin :
  • progressive form of MS (primary or secondary)
  • age between 18 and 80 years
  • Expanded Disability Status Scale (EDSS) between 3 and 7.5 at the beginning of biotin
  • treatment with biotin 300 mg per day at least one time, ongoing or stopped
  • no relapse in the year preceding biotin introduction
  • follow-up in an MS expert center
  • For the controls :
  • progressive form of MS (primary or secondary)
  • age between 18 and 80 years
  • Expanded Disability Status Scale (EDSS) between 3 and 7.5 at the baseline
  • EDMUS data base fulfilled at least three times during the two previous years
  • no relapse in the year preceding the baseline
  • follow-up in an MS expert center

Exclusion Criteria:

  • For all participants :
  • other disease modifying therapy (DMT) than interferon, methotrexate, mycophenolate mofetil, azathioprine, rituximab, ocrelizumab
  • For the controls :
  • treatment with biotin actually or in the past
  • follow-up in an MS expert center who do not provide exhaustive information about biotin

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): NCT03552211


Locations
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France
CHU Clermont-FERRAND
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
OFSEP (Observatoire Français de la Sclérose en Plaques)
SFSEP (Société Francophone de la Sclérose en Plaques)
MedDay Pharmaceuticals SA
Investigators
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Principal Investigator: Pierre CLAVELOU University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03552211     History of Changes
Other Study ID Numbers: CHU-388
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Multiple Sclerosis
Progressive Multiple Sclerosis
Biotin
Relapse
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Recurrence
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Biotin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs