Early MRI outcomes in participants with a first clinical demyelinating event at risk of multiple sclerosis in the ORACLE-MS study.

ABSTRACT:

Background

In the Phase 3, 96-week ORACLE-MS study, cladribine tablets 10 mg (3.5 or 5.25 mg/kg cumulative dosage over two years) significantly reduced lesions associated with multiple sclerosis versus placebo in participants following a first clinical demyelinating event (FCDE).

Objective

To determine the timing of effects of cladribine tablets on lesion activity assessed by magnetic resonance imaging (MRI).

Methods

This post hoc analysis assessed the effect of cladribine tablets versus placebo in ORACLE-MS on secondary MRI endpoints including T1 gadolinium-enhancing (Gd+), new or enlarging T2 lesions, and combined unique active lesions assessed on MRI scans performed at screening and every 3 months thereafter.

Results

Compared to placebo, cladribine ta

SUBMITTER: Freedman MS 

PROVIDER: S-EPMC7925953 | biostudies-literature | 2021 Jan-Mar

REPOSITORIES: biostudies-literature