Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis

NCT04821596 | Completed

• 1 other identifier: 2018/0408/HP
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the project is therefore to study and thus better understand the immunomodulatory / anti-inflammatory effects of cladribine during multiple sclerosis. Most current and developing therapies targeting the immune system have no effect on the progressive phase of MS, during which neurodegeneration plays a predominant role. As mentioned above, the very promising results of clinical trials with cladribine tablets for the early and progressive phase of the disease have revealed immunomodulatory properties and suggested potential neuroprotective effects. It therefore plans to further dissect one of these two parameters by designing in vitro studies with peripheral blood mononuclear cells (PBMC) from healthy donors and MS patients.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Description of cladribine's effects on immune system of multiple sclerosis patients

  Analysis of T cell response by flow cytometry

  Through study completion, of 1 year

Study Arms (1)

Multiple Sclerosis Patients

EXPERIMENTAL

Multiple Sclerosis Patients usually followed by Dr. Bourre as part of his consultation at the Rouen University Hospital will be offered the opportunity to participate in this study if they meet the selection criteria.

Other: biological collection

Interventions

biological collection OTHER

Six 5 mL heparinized tubes, approximately 24 mL of blood will be collected as per standard practice. The 5 tubes collected from a given individual will be transported directly to the laboratory. In the laboratory, peripheral blood mononuclear cells (PBMC) will be prepared for the various analyses. However, in order to minimize the effect of agents other than CoA in MS patients, it is necessary that peripheral blood mononuclear cells are collected before treatment is given: for RR MS patients treated with first-line drugs (IFNβ, glatiramer acetate, teriflunomide and dimethyl fumarate, ...), RR MS patients treated with second-line drugs (natalizumab and fingolimod, ...) and RR MS patients treated with third-line drugs (alemtuzumab, ...).

Multiple Sclerosis Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major Multiple Sclerosis (MS) Patients
• RR MS patients without treatment (early stage disease) Or RR MS patients treated with first-line compounds (IFNβ, glatiramer acetate, teriflunomide and dimethyl fumarate, ...).
• Or RR MS patients treated with second-line compounds (natalizumab and fingolimod, ...) RR MS patients treated with third-line compounds (alemtuzumab, ...) Or Patients with progressive MS
• Patients who have read and understood the information letter and signed the consent form
• Person affiliated to a social security system

You may not qualify if:

• Patients under 18 years of age or over 65 years of age,
• Patients who have benefited from immunosuppressive treatments for other autoimmune or cancerous pathologies,
• Patients receiving treatments for multiple sclerosis and participating in phase 2, 3 or 4 protocols will be excluded.
• Patients who have been treated for less than 1 year with cladribine, daclizumab, ocrelizumab, rituximab will be excluded.
• Patients who have received mitoxantrone or a stem cell transplant,
• Regulatory Criteria :
• Person deprived of liberty by an administrative or judicial decision
• Person placed under legal protection, sub-tutorship or curatorship

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 760031, 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 Design

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

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: March 29, 2021
• Study Start: July 13, 2020
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (1)