Status:
UNKNOWN
Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis
Lead Sponsor:
University Hospital, Rouen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 developin...
Detailed Description
Recent clinical trials have reported a remarkable therapeutic efficacy of cladribine tablets not only in the early and recurrent phases of the disease, but also in progressive multiple sclerosis. Howe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04821596
Start Date
July 13 2020
End Date
December 31 2021
Last Update
March 29 2021
Active Locations (1)
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1
Rouen University Hospital
Rouen, France, 760031