Last updated on May 2020

A Study to Evaluate Efficacy Safety and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

Brief description of study

Primary Objective:

To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric patients from 10 to <18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior Disease Modifying Therapy (DMT).

Secondary Objective:

To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).

Detailed Study Description

The duration of study per patient will be approximately 5 years and 5 months.

Clinical Study Identifier: NCT03368664

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Investigational Site Number 6430003

Novosibirsk, Russian Federation
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Investigational Site Number 6430005

Saint-Petersburg, Russian Federation
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Investigational Site Number 6430002

St-Petersburg, Russian Federation
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