THUR 172 Phase iv study of cladribine tablets and quality of life: clarify-ms

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Abstract

Background

Relapsing multiple sclerosis (RMS) negatively affects health-related quality of life (HRQoL).

Objective

An open-label, single-arm, exploratory Phase IV study in centres in Europe and Australia will assess HRQoL in RMS patients receiving CT 3.5 mg/kg (CT3.5).

Methods

Eligible patients will receive CT 3.5 (cumulative) over 2 years. HRQoL (Multiple Sclerosis Quality of Life-54 [MSQoL-54]) and other patient-reported outcomes (Fatigue Severity Scale; Hospital Anxiety and Depression Scale; Treatment Satisfaction Questionnaire for Medication v1.4) will be assessed at baseline, and at 6, 12, 24 months.

Methods

Other outcomes include AEs, MRI measures (T1 Gd+ lesions, T2 lesions, brain atrophy), number of relapses, and disability/functioning measures (EDSS; 9-Hole Peg Test; Timed 25-Foot Walk and Brief International Cognitive Assessment for Multiple Sclerosis). The sample size estimation is based on the power to detect a mean difference of 5 points in MSQoL-54 composite score at 24 months vs baseline.

Results

The study aims to recruit 356 adults with RMS by 2019. Final data are anticipated in 2022.

Conclusions

This study will explore the effects of CT on HRQoL outcomes, and describe the effects of CT on treatment satisfaction and disability/functioning.

Disclosure statement

The trial is sponsored by Merck KGaA, Darmstadt, Germany.

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