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Study of Diroximel Fumarate in the Real-World Setting

A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-US Study)
Stopped earlyRelapsing and progressiveNCT04746976

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Sponsor's Decision

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Percentage of Participants on Treatment with DRF at 1 Year

    1 year

Other measures (15)

  • Percentage of Participants on Treatment with DRF at 3 Months

    3 months

  • Percentage of Participants on Treatment with DRF at 2 Years

    2 years

  • Annualized Relapse Rate (ARR) with DRF

    At 1 and 2 years

    Relapses

  • Percentage of Participants Relapsed

    At 1 and 2 years

    Relapses

  • Change in Processing Speed Test (PST) Score from Baseline

    Baseline up to 2 years

    Thinking and memory

  • Change in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire

    Baseline up to 2 years

    Quality of life (reported by participants)

  • Change in Disability, as Measured by Patient Determined Disease Steps (PDDS)

    Baseline up to 2 years

  • Change in Work Productivity and Activity Impairment Due to Multiple Sclerosis (WPAI- MS) Scores from Baseline

    Baseline up to 2 years

  • Number of Participants with Gastrointestinal (GI) Adverse Events (AEs)

    Up to 32 months

    Safety

  • Number of Participants with AEs Leading to Treatment Discontinuation

    Up to 32 months

Who could take part

Relapsing and progressive · 18 and over

Key Inclusion Criteria: * Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the USPI. * DRF prescribed and planned to be initiated within 60 days after enrollment. Key Exclusion Criteria: * History of gastric bypass or required use of feeding tubes. * Have received prior treatment with DRF. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs) and to explore the real-world safety profile of DRF (ie, gastrointestinal [GI] tolerability, lymphocyte dynamics, adverse events [AEs] leading to discontinuation, and serious adverse events [SAEs]).

Papers

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    Related trials

    History

      1. Started

        Mar 2021

      2. Main results due

        Apr 2023

      3. Finished

        Apr 2023

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