A Phase 4 interventional study of Cladribine 10 mg oral tablet in Multiple Sclerosis, Relapsing-Remitting, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Phase 4, Interventional, and Treatment
Multiple sclerosis (MS) is a chronic, immune-mediated, demyelinating disease of the central nervous system. Typical brain lesions of the disease may be partially repaired by an endogenous remyelination process which is limited and tends to deplete over the course of the disease. Cladribine tablets are an approved treatment that promotes selective lymphocyte depletion, reducing the inflammatory activity of the disease. The present study is based on the hypothesis that improved inflammatory control through cladribine tablets provides a tissue microenvironment more favorable for remyelination of brain lesions in MS. This hypothesis will be evaluated by a single-arm, open-label, phase IV, single-center, proof-of-concept clinical trial in which 10 participants with relapsing-remitting, highly active MS, relatively early in the course of the disease, will receive conventional treatment with cladribine tablets and will be followed-up for 48 months. Neurological, neuropsychological and magnetic resonance imaging (MRI) parameters will be measured. Remyelination will be assessed by a novel MRI technique called the q-Space myelin map. Additionally, the peripheral blood lymphocyte and cytokine profiles will be evaluated in order to understand the immunological aspects that influence the remyelination capacity in patients treated with cladribine tablets. The study will be conducted in accordance with current regulations governing clinical research in Brazil.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Pontificia Universidade Católica do Rio Grande do Sul is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
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Participants who meet all of the following criteria will be included:
Exclusion criteria:
Participants who meet any of the following criteria will be excluded:
Drug: Cladribine 10 mg oral tablet
Cladribine tablets (Mavenclad®, Merck KGaA, Darmstadt, Germany) will be given according to the label with a cumulative dose of 3.5 mg/kg body weight distributed over 2 years as one treatment course of 1.75 mg/kg per year. Each treatment course will consist of 2 weeks of treatment, one at the beginning of the first month and one at the beginning of the second month of the respective year of treatment. Each treatment week will consist of 4 or 5 days in which the participant will receive 10 mg or 20 mg (1 or 2 tablets, respectively) as a single daily dose, depending on body weight, according to the tables available in label. Upon completion of the two treatment courses, no further courses will be required in years 3 and 4.
Also known as: Mavenclad
Proportion of remyelinated lesions (as assessed by neuroradiologist) in q-Space myelin map
Time frame: 36 months after initiation of cladribine tablets treatment
Median "lesion ratio" (i.e., myelin index: lesion signal / normal appearing white matter signal) in q-Space myelin map
Time frame: 36 months after initiation of cladribine tablets treatment
Mean signal intensity of lesions in q-Space myelin map
Time frame: 36 months after initiation of cladribine tablets treatment
Correlation between lymphocyte profile and remyelination parameters in q-Space myelin map
Time frame: Transversally (at months 0, 12, 24, and 36) and longitudinally (over 36 months following initiation of cladribine tablets treatment)
Correlation between cytokine profile and remyelination parameters in q-Space myelin map
Time frame: Transversally (at months 0, 12, 24, and 36) and longitudinally (over 36 months following initiation of cladribine tablets treatment)
Correlation between remyelination parameters in q-Space myelin map and evolution of clinical scores (annualized relapse rate, EDSS, MSFC and their subtests)
Time frame: Over 36 months following initiation of cladribine tablets treatment
Correlation between remyelination parameters in q-Space myelin map and evolution of neuropsychological scores (BICAMS and MFIS subtests)
Time frame: Over 36 months following initiation of cladribine tablets treatment
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Pontificia Universidade Católica do Rio Grande do Sul