Multiple Sclerosis

NCT03974997 | Unknown

• 1 other identifier: 2019-12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A significant variation in the serum concentration of the circulating cytokine TWEAK is associated with the onset of an inflammatory attack of MS. Study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The serum concentration of soluble TWEAK

  We will then compare the soluble TWEAK concentrations observed in patients with anti-TWEAK antibodies and in patients without anti-TWEAK antibodies. We will study the correlation between the concentrations of soluble TWEAK and those of soluble TNF.

  1 year

Study Arms (1)

serum concentration changes in cytokine TWEAK

OTHER

We will perform a prospective study in which 50 patients with multiple sclerosis in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium).

Diagnostic Test: Determination of the circulating serum concentration of cytoquine TWEAK

Interventions

Determination of the circulating serum concentration of cytoquine TWEAK DIAGNOSTIC_TEST

Blood samples (20 ml of blood on dry tube) by venipuncture at the bend of the elbow will be made at T0, then monthly for a period of 1 year . The sera will be isolated by centrifugation and then frozen at -80 degrees Assays of the soluble form of TWEAK and TNF will be performed by ELISA blot technique developed by the team.

serum concentration changes in cytokine TWEAK

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 45 years
• the first inflammatory and demyelinating episode of the central nervous system affecting the optic nerve, the spinal cord
• No neurological antecedent demyelinating
• respect of the revised diagnostic criteria of Mac Donald 2010
• handicap degree between 0 and 5 at the time of diagnosis

You may not qualify if:

• pregnant woman

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jean-Olivier ARNAUD

  Assistance Publique des Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Sophie DESPLAT-JEGO

CONTACT

+ 33 4 91 38 39 07; sophie.jego-desplat@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center interventional study with minimal risks and constraints on a cohort of MS patients. Patients with clinically isolated syndrome suggestive of MS will be included prospectively and consecutively.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

FR (1)