Multiple Sclerosis: Chi3L1 and Treatment Efficacy

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289675
• Other study ID #: CPRC 2018 / CHI3L1-MATHEY/MS
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Baseline to month 15
Secondary	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
Secondary	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".	Baseline to month 15
Secondary	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".	Baseline to month 15
Secondary	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".	Baseline to month 15