NCT03744351

Brief Summary

Interventional study with minimal risks and constraints, prospective, monocentric.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4.3 years

First QC Date

November 14, 2018

Last Update Submit

April 9, 2024

Conditions

Multiple Sclerosis

Keywords

Follicular helper T cellsB cellsDifferentiation

Outcome Measures

Primary Outcomes (1)

  • Plasmablasts frequency

    Frequency of plasmablasts CD38hiCD27hi obtained after 6 days of differentiation of B cells in vitro, analyzed by flow cytometry

    At Day 6 after differentiation of B cells

Study Arms (4)

Healthy volunteer

OTHER

* 45 subjects * A single visit

Other: Biological Samples

Clinically Isolated Syndrome

OTHER

• 35 subjects

Other: Biological Samples

Non-MS patients with neurological inflammatory disease

OTHER

• 30 subjects

Other: Biological Samples

MS patients (remitting or progressive untreated)

OTHER

* 30 untreated remittent patients * 30 progressive untreated patients

Other: Biological Samples

Interventions

Biological SamplesOTHER

Venous sampling that is performed solely for the purpose of research. The total blood volume taken is 80 ml maximum (8 tubes of 10 ml).

Healthy volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Regarding MS patients (remitting or progressive untreated):
  • Adult (age greater than or equal to 18 years) of both sexes;
  • MS fulfilling the criteria of McDonald 2017;
  • Remittent or progressive form;
  • No immunomodulatory or immunosuppressive therapy for at least 3 months;
  • Free, informed and written consent signed by the patient.
  • Regarding Clinically Isolated Syndrome:
  • Adult (age greater than or equal to 18 years) of both sexes;
  • Clinically isolated syndrome suggestive of MS (at least two typical lesions in two different locations);
  • Patient receiving a Lumbar Puncture (PL) for diagnostic purposes;
  • No immunomodulatory or immunosuppressive therapy for at least 3 months;
  • Free, informed and written consent signed by the patient.
  • Regarding non-MS patients with neurological inflammatory disease:
  • Adult (age greater than or equal to 18 years) of both sexes;
  • Patient with non-MS neurological inflammatory disease (examples: meningitis, neurolupus, neurosarcoidosis...);
  • +6 more criteria

You may not qualify if:

  • Regarding all patients:
  • Pregnancy;
  • Breastfeeding;
  • Treatment with corticotherapy in the last month;
  • Patient not affiliated to social security;
  • Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
  • Regarding healthy volunteers:
  • Pregnancy;
  • Breastfeeding;
  • Not affiliated to social security;
  • Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laure Michel

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

February 25, 2019

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

FR(1)