Multiple Sclerosis
Conditions
Brief 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. 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.
Interventions
DRUGInterferon-Beta
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.
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Inclusion criteria
* 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
Exclusion criteria
* Objection to the use of personal data for research purpose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statistical association between the baseline chitinase 3-like 1 serum level and being responder at year one | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Threshold chitinase 3-like 1 serum level at baseline to distinguish responders from non-responders | Baseline to month 15 | Threshold measure that discriminates responders and non-responders at month 15 in each group |
| Statistical association between the baseline chitinase 3-like 1 cerebrospinal fluid level and being responder at year one | 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. |
| Statistical association between the baseline neurofilaments light chains cerebrospinal fluid level and being responder at year one | 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. |
| Statistical association between the baseline interleukin 6 cerebrospinal fluid level and being responder at year one | 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. |
Outcome results
None listed