Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pontificia Universidade Católica do Rio Grande do Sul
With
Merck S.A., Brazil, an affiliate of Merck KGaA, Darmstadt, Germany
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants who meet all of the following criteria will be included:
Consent to participate in the study by signing the ICF;
Age between 18 and 55 years, inclusive;
Relapsing-remitting multiple sclerosis diagnosed according to 2017 revised McDonald's criteria;
Highly active disease, defined as 1) occurrence of ≥2 relapses within 12 months prior to study enrolment, regardless of whether or not treatment with another disease-modifying drugs (DMD) was present; or 2) occurrence of ≥1 relapse in the previous 12 months during treatment with another DMD, together with ≥1 gadolinium-enhanced T1 lesion or ≥9 T2/FLAIR lesions on MRI performed during the same period;
Disease duration (time since first relapse) ≤4 years;
EDSS score ≤5.0;
Eligibility for treatment with cladribine tablets, according to the label approved in Brazil;
For women or men of childbearing potential: agreement to use effective contraceptive method as recommended in cladribine tablets label.
You may not be if
Participants who meet any of the following criteria will be excluded:
Contraindications to the use of cladribine tablets (as per the label), including (but not limited to) baseline lymphopenia (\<1,000 cells/ mm³), active neoplasm or neoplasm within the last 5 years, active infections (especially tuberculosis, hepatitis B or C and HIV), latent tuberculosis without proper treatment, moderate to severe renal or hepatic impairment, use of immunosuppressants or immunosuppression for another cause;
Pregnancy or lactation;
Presence of other medical conditions or current or previous use of another therapy capable of interfering with neurological, neuropsychological, radiological or laboratory evaluation, as per investigator's judgment;
Contraindications to MRI or gadolinium use;
Inability to adhere to study procedures, as per investigator's judgment.
Clareo Health | Effects of Oral Cladribine on Remyelination and Inflammation in Multiple Sclerosis Patients
