056 Efficacy and safety of the Bruton’s tyrosine kinase inhibitor evobrutinib (M2951) in patients with relapsing multiple sclerosis over 48 weeks: a randomized, placebo-controlled, phase 2 study

Abstract

To generate high quality safety data, multiple Sclerosis (MS) registries have begun to collect safety data more systematically, and use MedDRA coding of serious adverse events (SAE) to harmonise data collection across registries. Major MS registries and seven pharmaceutical companies all agreed on a common safety protocol, which is informing a standardised approach to the use of MS registries for SAE collection. CLARION is a prospective, multi-country, observational cohort study involving nine MS registries covering 14 countries. CLARION will evaluate the safety profile, in terms of adverse events of special interest (AESI), of patients initiating cladribine tablets (CT, n=4,000) versus those initiating fingolimod (n=4,000). CLARION combines primary (Germany) and secondary data (other countries) and is projected to last up to 15 years with 10 years of follow-up for each included patient. Enrolled patients are those newly initiating CT or fingolimod according to the local label for MS after the date of CT launch in the relevant country or, in countries with primary data collection, after providing signed informed consent (<24 weeks after initiation of CT or fingolimod treatment). Patients are excluded if they received fingolimod prior to CT or if they received CT prior to fingolimod. Analysis of merged data from the different registries will be performed. Adjusted incidence rate and adjusted incidence rate ratios of each AESI and corresponding 95% confidence intervals, will be estimated. Quality assurance, focusing on registry processes and practices as well as data quality will be tracked using pre-specified metrics and analysis plans. CLARION will provide safety evidence for neurologists and patients to assist the treatment decision process for patients with highly active relapsing MS.Copyright © 2019