Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)

Launched by NEUROMED IRCCS · Oct 7, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the role of specific genetic variations (known as ADA SNPs) in people with relapsing multiple sclerosis (RMS). RMS is a type of multiple sclerosis where patients experience episodes of neurological symptoms that can vary greatly from person to person. The trial aims to understand how these genetic differences might affect how patients respond to treatment, particularly with a medication called Cladribine. The goal is to identify potential biomarkers, or biological markers, that could help predict how different individuals will react to treatments, which is currently a challenge in managing this disease.

To be eligible for the trial, participants must be at least 18 years old and have highly active RMS, meaning they have had one or more relapses in the past year. They should also have a certain level of physical ability as measured by a specific scale (EDSS score of 5.0 or less) and meet other health criteria, such as having a normal lymphocyte count. Participants can expect to undergo a variety of assessments during the study, and their involvement may help improve understanding and treatment of RMS in the future. It’s important to note that individuals with certain health conditions or who are currently on specific medications may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects ≥ 18 years old
• 2. 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;
• • 3. Normal lymphocyte count (absolute values 1.0-3.0×109/l) according to Cladribine local labelling;
• • 4. EDSS score ≤5.0.
• Exclusion Criteria:
• • 1. Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab;
• • 2. Positive hepatitis C or hepatitis B surface antigen test and/or hepatitis B core antibody test for IgG and/or IgM;
• • 3. Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result;
• • 4. Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids;
• • 5. History of tuberculosis, presence of active tuberculosis, or latent tuberculosis;
• • 6. Evidence or suspect of PML in MRI;
• • 7. Active malignancy or history of malignancy.
• • 8. Pregnant or lactating women
• • 9. Currently receiving interferon