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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-Beta | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
If any of these criteria is lacking, then the patient is considered as "non-responder". | Baseline to month 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to month 15 |
| Statistical association between the baseline chitinase 3-like 1 cerebrospinal fluid level and being "responder" at year one |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Mathey, MSc, MD | Hôpital Central - service de Neurologie - CHRU Nancy | Principal Investigator |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D000069462 | Dimethyl Fumarate |
| C527525 | teriflunomide |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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Blood samples : chitinase 3-like 1 level Cerebrospinal fluid samples : chitinase 3-like 1, neurofilaments light chains and interleukin 6 levels
|
Significant associations in each group of treatment Being "responder" means the presence of the four following :
If any of these criteria is lacking, then the patient is considered as "non-responder". |
| 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 :
If any of these criteria is lacking, then the patient is considered as "non-responder". | 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 :
If any of these criteria is lacking, then the patient is considered as "non-responder". | Baseline to month 15 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |