Multiple SclerosisNCT04289675
Multiple Sclerosis: Chi3L1 and Treatment Efficacy
An observational study of Multiple Sclerosis, run by Central Hospital, Nancy, France.
Trial summary
Chitinase 3-like 1 (Chi3L1) is a Human protein synthetized by inflammatory cells. Its serum level increases in case of autoimmune diseases, and especially during multiple sclerosis (MS). There is a need for biological markers predictive of treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon-Beta
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Dec 2019
- How long will I take part?
- 2 Years
- 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 55 years
- All sexes
- Adult
Study population: Patients are selected from the Registre Lorrain des Scléroses en Plaques (ReLSEP). Demographical, clinical and paraclinical data are already collected in this database. Biological tests will be performed on their relative blood and cerebrospinal fluid samples, already taken and kept in the Centre de Ressources Biologiques Lorrain.
Who may be able to join
- Relapsing-onset multiple sclerosis according to the 2017 McDonald criteria
- Blood and cerebrospinal fluid samples collected at diagnostic assessment from 2012 January 1st and kept in the Centre de Ressources Biologiques Lorrain
- First platform disease modifying drugs : interferon-Beta, dimethyl fumarate or teriflunomide, introduced during the first 3 months after the diagnostic assessment
- Disease modifying drugs maintained at least 3 months
- Follow-up during at least 15 months after the first disease modifying drug initiation
- At least one brain magnetic resonance imaging with gadolinium injection between months 3 and 15 after disease modifying drug initiation
Who cannot join
- Objection to the use of personal data for research purpose
About this study
Official title: Chi3L1: A Marker of Efficacy of Platform Treatments in Relapsing-onset Multiple Sclerosis: A Prognostic Study on Existing Clinical Data and Biological Samples
Chitinase 3-like 1 (Chi3L1) is a Human protein synthetized by inflammatory cells. Its serum level increases in case of autoimmune diseases, and especially during multiple sclerosis (MS). There is a need for biological markers predictive of treatment efficacy. MS outcomes one year from treatment initiation are predictive of long-term treatment efficacy. The hypothesis is that serum Chi3L1 level before treatment initiation could predict one year MS outcomes.
Primary objective: to show an association between the serum Chi3L1 level at diagnostic assessment and the clinical and radiological efficacy one year from initiation of the first disease modifying treatment (interferon beta, dimethyl fumarate or teriflunomide) in relapsing-onset multiple sclerosis (MS).
Secondary objectives: to determine the threshold value of the serum Chi3L1 level predicting the efficacy of treatment, and the added value of other potential biomarkers in cerebrospinal fluid collected at diagnostic assessment: Chi3L1, light chains of neurofilaments and interleukin 6.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon-Beta
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-BetaDrug
Also called Dimethyl fumarate, Teriflunomide
Theses drugs have been administered as part of routine care. Biological samples that will be analyzed (blood and cerebrospinal fluid) have been taken as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| Interferon-Beta | Patients with first treatment : interferon beta (1a subcutaneous 22 or 44 µg thrice a week OR 1a intramuscular 30 µg once a week OR 1b subcutaneous 250 µg every other day OR 1a PEGylated subcutaneous 125 µg every two weeks) Receives: Drug: Interferon-Beta | |
| Dimethyl fumarate | Patients with first treatment : dimethyl fumarate (oral, 240 mg twice a day) | |
| Teriflunomide | Patients with first treatment : teriflunomide (oral, 14 mg once a day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical association between the baseline chitinase 3-like 1 serum level and being "responder" at year one
Significant associations in each group of treatment
Being "responder" means the presence of the four following :
- No treatment withdrawal between months 3 and 15 after treatment initiation for reason of inefficacy
- No relapse between months 3 and 15
- No increase of at least one point on the expanded disability status scale between months 3 and 15
- No gad-enhancing lesion on any magnetic resonance imaging scan between months 3 and 15
If any of these criteria is lacking, then the patient is considered as "non-responder".
Measured: Baseline to month 15
Secondary outcomes (4)
Threshold chitinase 3-like 1 serum level at baseline to distinguish responders from non-responders
Threshold measure that discriminates responders and non-responders at month 15 in each group
Measured: Baseline to month 15
Statistical association between the baseline chitinase 3-like 1 cerebrospinal fluid level and being "responder" at year one
Significant associations in each group of treatment
Being "responder" means the presence of the four following :
- No treatment withdrawal between months 3 and 15 after treatment initiation for reason of inefficacy
- No relapse between months 3 and 15
- No increase of at least one point on the expanded disability status scale between months 3 and 15
- No gad-enhancing lesion on any magnetic resonance imaging scan between months 3 and 15
If any of these criteria is lacking, then the patient is considered as "non-responder".
Measured: Baseline to month 15
Statistical association between the baseline neurofilaments light chains cerebrospinal fluid level and being "responder" at year one
Significant associations in each group of treatment
Being "responder" means the presence of the four following :
- No treatment withdrawal between months 3 and 15 after treatment initiation for reason of inefficacy
- No relapse between months 3 and 15
- No increase of at least one point on the expanded disability status scale between months 3 and 15
- No gad-enhancing lesion on any magnetic resonance imaging scan between months 3 and 15
If any of these criteria is lacking, then the patient is considered as "non-responder".
Measured: Baseline to month 15
Statistical association between the baseline interleukin 6 cerebrospinal fluid level and being "responder" at year one
Significant associations in each group of treatment
Being "responder" means the presence of the four following :
- No treatment withdrawal between months 3 and 15 after treatment initiation for reason of inefficacy
- No relapse between months 3 and 15
- No increase of at least one point on the expanded disability status scale between months 3 and 15
- No gad-enhancing lesion on any magnetic resonance imaging scan between months 3 and 15
If any of these criteria is lacking, then the patient is considered as "non-responder".
Measured: Baseline to month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Jan 2012
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Mathey, MSc, MD, Principal investigator, Hôpital Central - service de Neurologie - CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289675
- Sponsor's protocol ID
- CPRC 2018 / CHI3L1-MATHEY/MS
- Status last verified
- Dec 2019
- First submitted
- 27 Dec 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chi3L1: A Marker of Efficacy of Platform Treatments in Relapsing-onset Multiple Sclerosis: A Prognostic Study on Existing Clinical Data and Biological Samples
- ClinicalTrials.gov ID
- NCT04289675
- Acronym / sponsor ID
- CPRC 2018 / CHI3L1-MATHEY/MS
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Feb 2020 (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.
Chitinase 3-like 1 (Chi3L1) is a Human protein synthetized by inflammatory cells. Its serum level increases in case of autoimmune diseases, and especially during multiple sclerosis (MS). There is a need for biological markers predictive of treatment efficacy. MS outcomes one year from treatment initiation are predictive of long-term treatment efficacy. The hypothesis is that serum Chi3L1 level before treatment initiation could predict one year MS outcomes.
Primary objective: to show an association between the serum Chi3L1 level at diagnostic assessment and the clinical and radiological efficacy one year from initiation of the first disease modifying treatment (interferon beta, dimethyl fumarate or teriflunomide) in relapsing-onset multiple sclerosis (MS).
Secondary objectives: to determine the threshold value of the serum Chi3L1 level predicting the efficacy of treatment, and the added value of other potential biomarkers in cerebrospinal fluid collected at diagnostic assessment: Chi3L1, light chains of neurofilaments and interleukin 6.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interferon-Beta | – | Drug: Interferon-BetaPatients with first treatment : interferon beta (1a subcutaneous 22 or 44 µg thrice a week OR 1a intramuscular 30 µg once a week OR 1b subcutaneous 250 µg every other day OR 1a PEGylated subcutaneous 125 µg every two weeks) |
| Dimethyl fumarate | – | –Patients with first treatment : dimethyl fumarate (oral, 240 mg twice a day) |
| Teriflunomide | – | –Patients with first treatment : teriflunomide (oral, 14 mg once a day) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients are selected from the Registre Lorrain des Scléroses en Plaques (ReLSEP). Demographical, clinical and paraclinical data are already collected in this database. Biological tests will be performed on their relative blood and cerebrospinal fluid samples, already taken and kept in the Centre de Ressources Biologiques Lorrain.
Key inclusion criteria (6 listed)
- Relapsing-onset multiple sclerosis according to the 2017 McDonald criteria
- Blood and cerebrospinal fluid samples collected at diagnostic assessment from 2012 January 1st and kept in the Centre de Ressources Biologiques Lorrain
- First platform disease modifying drugs : interferon-Beta, dimethyl fumarate or teriflunomide, introduced during the first 3 months after the diagnostic assessment
- Disease modifying drugs maintained at least 3 months
- Follow-up during at least 15 months after the first disease modifying drug initiation
Key exclusion criteria (1 listed)
- Objection to the use of personal data for research purpose
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 |
|---|---|---|
| Interferon-BetaAlso: Dimethyl fumarate, TeriflunomideTheses drugs have been administered as part of routine care. Biological samples that will be analyzed (blood and cerebrospinal fluid) have been taken as part of routine care. | Drug | Interferon-Beta |
Primary outcome
Statistical association between the baseline chitinase 3-like 1 serum level and being "responder" at year one
Time frame: Baseline to month 15
Significant associations in each group of treatment Being "responder" means the presence of the four following : * No treatment withdrawal between months 3 and 15 after treatment initiation for reason of inefficacy * No relapse between months 3 and 15 * No increase of at least one point on the expanded disability status scale between months 3 and 15 * No gad-enhancing lesion on any magnetic resonance imaging scan between months 3 and 15 If any of these criteria is lacking, then the patient is considered as "non-responder".
4 secondary outcomes
Threshold chitinase 3-like 1 serum level at baseline to distinguish responders from non-responders
Time frame: Baseline to month 15
Statistical association between the baseline chitinase 3-like 1 cerebrospinal fluid level and being "responder" at year one
Time frame: Baseline to month 15
Statistical association between the baseline neurofilaments light chains cerebrospinal fluid level and being "responder" at year one
Time frame: Baseline to month 15
Statistical association between the baseline interleukin 6 cerebrospinal fluid level and being "responder" at year one
Time frame: Baseline to month 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Guillaume Mathey, MSc, MD principal investigator
Hôpital Central - service de Neurologie - CHRU Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Central Hospital, Nancy, 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Statistical association between the baseline chitinase 3-like 1 serum level and being "responder" at year one (time frame: Baseline to month 15). 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 9 Mar 2020.