Clinical trial NCT04289675: Multiple Sclerosis: Chi3L1 and Treatment Efficacy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Statistical association between the baseline chitinase 3-like 1 serum level and being "responder" at year one
timeFrame: Baseline to month 15
Secondary outcomes:
measure: Threshold chitinase 3-like 1 serum level at baseline to distinguish responders from non-responders
timeFrame: Baseline to month 15
measure: Statistical association between the baseline chitinase 3-like 1 cerebrospinal fluid level and being "responder" at year one
timeFrame: Baseline to month 15
measure: Statistical association between the baseline neurofilaments light chains cerebrospinal fluid level and being "responder" at year one
timeFrame: Baseline to month 15
measure: Statistical association between the baseline interleukin 6 cerebrospinal fluid level and being "responder" at year one
timeFrame: Baseline to month 15
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Central - service de Neurologie - CHRU Nancy
name: Guillaume Mathey, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References: