RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw)

Stopped earlyPhase 4Relapsing MSNCT02117050

What it found

Stopped

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

Reason given: recruitment challenges

What was tested

Treatment tested

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Rebif® Via Rebidose® Auto-injector00

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change From Baseline in Treatment Satisfaction Score Determined by the Global Satisfaction Sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24

    Baseline, Week 24

    Quality of life (reported by participants)

Other measures (8)

  • Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24

    Baseline, Week 24

    Walking and mobility

  • Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24

    Baseline, Week 24

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

  • Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24

    Baseline, Week 12 and Week 24

    Quality of life (reported by participants)Safety

  • Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24

    Baseline, Week 24

    Quality of life (reported by participants)Safety

  • Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12

    Baseline, Week 12

    Quality of life (reported by participants)Safety

  • Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24

    Baseline, Week 24

  • Change From Baseline in Number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24

    Baseline, Week 24

    MRI lesions

  • Annualized Relapse Rate (ARR)

    Week 24

    Relapses

Who could take part

Relapsing MS · 18 to 65 · EDSS 0 to 5.0

Show the full criteria

Inclusion criteria

Key inclusion Criteria: * Diagnosis of relapsing form of MS * Have declared a desire/plan to discontinue treatment with Tecfidera due to tolerability issues and/or lack of efficacy * Expanded Disability Status Scale (EDSS) score 0 to 5.0 inclusive * Other protocol defined inclusion criteria could apply Key exclusion Criteria: * Pregnant or lactating * Significant renal or hepatic impairment or other significant disease that would compromise adherence and completion of the trial * Other protocol defined exclusion criteria could apply

Exclusion criteria

Not separately supplied in the registry.

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

About this trial

In the sponsor's words

This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering discontinuing treatment with Tecfidera™.

Papers

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    History

      1. Started

        Jun 2014

      2. Main results due

        Apr 2015

      3. Finished

        Apr 2015

      4. Results posted

        Jan 2017

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