Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis

NCT03552211 | Unknown

• 1 other identifier: CHU-388
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

Progressive Multiple Sclerosis

Keywords

Multiple Sclerosis; Progressive Multiple Sclerosis; Biotin; Relapse

Outcome Measures

Primary Outcomes (1)

• Relapses with biotin

  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

  at day 1 (through study completion, an average of 1 year)

Secondary Outcomes (2)

• Clinical characteristics of the relapses with biotin

  at day 1 (through study completion, an average of 1 year)

• Characteristics of patients with relapse with biotin

  at day 1 (through study completion, an average of 1 year)

Study Arms (2)

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

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

Interventions

biotin DRUG

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.

Patients treated with biotin

propensity score OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Progressive forms of Multiple Sclerosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• OFSEP (Observatoire Français de la Sclérose en Plaques): collaborator
• SFSEP (Société Francophone de la Sclérose en Plaques): collaborator
• MedDay Pharmaceuticals SA: collaborator

Study Sites (1)

CHU Clermont-FERRAND

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Recurrence

Interventions

Biotin; Propensity Score

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pierre CLAVELOU

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 11, 2018
• Study Start: May 30, 2018
• Primary Completion: February 1, 2019
• Study Completion: April 30, 2019
• Last Updated: June 11, 2018

Record last verified: 2018-05

Locations

FR (1)