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NCT Number: NCT04289675

Multiple Sclerosis: Chi3L1 and Treatment Efficacy

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dimethyl fumarate, Teriflunomide

Primary outcomes

  1. 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".

Secondary outcomes

  1. Threshold chitinase 3-like 1 serum level at baseline to distinguish responders from non-responders

    Time frame: Baseline to month 15

    Threshold measure that discriminates responders and non-responders at month 15 in each group

  2. Statistical association between the baseline chitinase 3-like 1 cerebrospinal fluid 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".

  3. Statistical association between the baseline neurofilaments light chains cerebrospinal fluid 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. Statistical association between the baseline interleukin 6 cerebrospinal fluid 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".

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Chi3L1: A Marker of Efficacy of Platform Treatments in Relapsing-onset Multiple Sclerosis: A Prognostic Study on Existing Clinical Data and Biological Samples

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2020
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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