Status:
RECRUITING
Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)
Lead Sponsor:
Neuromed IRCCS
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
Multiple Sclerosis (MS) is a chronic autoimmune demyelinating disease of the central nervous system (CNS), which is highly heterogeneous in terms of clinical symptoms, MS subtypes and treatment respon...
Detailed Description
The therapeutic landscape for multiple sclerosis (MS) is rapidly evolving. For the past 25 years, there has been an accelerating inclusion of new immunomodulating drugs. MS immunotherapies may also be...
Eligibility Criteria
Inclusion
- Male or female subjects ≥ 18 years old
- Subjects candidate to be treated with Cladribine (2-CdA) according to clinical practice and meeting the SmPc requirements:
- Body weight ≥ 40 Kg
- Highly active RMS as defined by: One relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs); two or more relapses in the previous year, whether on DMD treatment or not;
- Normal lymphocyte count (absolute values 1.0-3.0×109/l) according to Cladribine local labelling;
- EDSS score ≤5.0.
Exclusion
- Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab;
- Positive hepatitis C or hepatitis B surface antigen test and/or hepatitis B core antibody test for IgG and/or IgM;
- Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result;
- Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids;
- History of tuberculosis, presence of active tuberculosis, or latent tuberculosis;
- Evidence or suspect of PML in MRI;
- Active malignancy or history of malignancy.
- Pregnant or lactating women
- Currently receiving interferon
Key Trial Info
Start Date :
September 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04121065
Start Date
September 7 2020
End Date
June 1 2025
Last Update
March 29 2024
Active Locations (1)
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1
IRCCS Neuromed
Pozzilli, Isernia, Italy, 86077