Multiple Sclerosis: Chi3L1 and Treatment Efficacy

NCT ID: NCT04289675

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2019-12-01

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Interferon-Beta

Intervention Type: 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.

Dimethyl fumarate

Patients with first treatment : dimethyl fumarate (oral, 240 mg twice a day)

No interventions assigned to this group

Teriflunomide

Patients with first treatment : teriflunomide (oral, 14 mg once a day)

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Dimethyl fumarate; Teriflunomide

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Mathey, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Central - service de Neurologie - CHRU Nancy

Other Identifiers

CPRC 2018 / CHI3L1-MATHEY/MS

Identifier Type: -

Identifier Source: org_study_id