Progressive Multiple SclerosisIPBio-SePNCT03552211
Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis
An observational study of Progressive Multiple Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- biotin and propensity score
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Progressive forms of Multiple Sclerosis
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- To determine if high dose biotin increase the clinical inflammatory activity of patients with a progressive form of MS.
- To compare the clinical characteristics of the relapses that occurred with biotin or not.
- 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.
Read the 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.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- biotin, propensity score
- Keywords
- Multiple Sclerosis, Progressive Multiple Sclerosis, Biotin, Relapse
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biotinDrug
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.
propensity scoreOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: propensity score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1 (through study completion, an average of 1 year)
Secondary outcomes (2)
Clinical characteristics of the relapses with biotin
To compare the clinical characteristics of the relapses that occurred with biotin or not.
Measured: at day 1 (through study completion, an average of 1 year)
Characteristics of patients with relapse with biotin
To describe the characteristics of the patients with a clinical inflammatory activity with biotin
Measured: at day 1 (through study completion, an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start30 May 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- OFSEP (Observatoire Français de la Sclérose en Plaques), SFSEP (Société Francophone de la Sclérose en Plaques), MedDay Pharmaceuticals SA
- Responsible party
- Sponsor
- Investigators
- Pierre CLAVELOU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552211
- Sponsor's protocol ID
- CHU-388
- Acronym
- IPBio-SeP
- Status last verified
- May 2018
- First submitted
- 25 Apr 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03552211
- Acronym / sponsor ID
- IPBio-SeP / CHU-388
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Progressive Multiple Sclerosis, Biotin, Relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- OFSEP (Observatoire Français de la Sclérose en Plaques), SFSEP (Société Francophone de la Sclérose en Plaques), MedDay Pharmaceuticals SA
- Study start
- 30 May 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine if high dose biotin increase the clinical inflammatory activity of patients with a progressive form of MS.
- To compare the clinical characteristics of the relapses that occurred with biotin or not.
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with biotin | – | Drug: biotinThis 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 | – | Other: propensity scoreThis 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Progressive forms of Multiple Sclerosis
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biotinThis 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 | Patients treated with biotin |
| propensity scoreThis 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 | Control patients |
Primary outcome
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
2 secondary outcomes
Clinical characteristics of the relapses with biotin
Time frame: at day 1 (through study completion, an average of 1 year)
Characteristics of patients with relapse with biotin
Time frame: at day 1 (through study completion, an average of 1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre CLAVELOU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Multiple Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapses with biotin (time frame: at day 1 (through study completion, an average of 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.