Multiple Sclerosis: Chi3L1 and Treatment Efficacy

Central Hospital, Nancy, France

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon-Beta

Study type: Observational

Funder types: Other

Identifiers

NCT04289675

CPRC 2018 / CHI3L1-MATHEY/MS

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

63 participants in 3 patient groups

Interferon-Beta

Description:

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)

Treatment:

Drug: Interferon-Beta

Dimethyl fumarate

Description:

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

Teriflunomide

Description:

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