Stopped earlyRelapsing MSNCT02949908

What it found

Stopped early

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

Reason given: Delay in site selection and recruitment.

What was tested

Treatment tested

Results by group

Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)

Month 6

GroupValueIntervalNumber analysed
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)5 Units on a scale1

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)20 (0.0%)0

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

  • Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)

    Month 6

    Quality of life (reported by participants)
  • Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)

    Month 12

    Quality of life (reported by participants)

Other measures (15)

  • Annualized Relapse Rate (ARR)

    Month 12

    Relapses
  • Number of Participants With Adherence to Treatment

    Month 6 and Month 12

    Quality of life (reported by participants)
  • Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12

    Month 6, Month 12

    Quality of life (reported by participants)
  • Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation

    Baseline

  • Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)

    up to 12 months

    RelapsesQuality of life (reported by participants)
  • Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence

    up to 12 months

    Quality of life (reported by participants)
  • Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation

    up to 12 months

    Quality of life (reported by participants)
  • Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)

    up to 12 months

    RelapsesQuality of life (reported by participants)
  • Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence

    up to 12 months

    Quality of life (reported by participants)
  • Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation

    up to 12 months

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 65

Inclusion Criteria: * Male or female, 18 to 65 years of age (both inclusive), at the time of informed consent * Participants diagnosed with RRMS according to McDonald criteria 2010 * Participants have discontinued treatment with dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), glatiramer acetate (Copaxone®), intramuscular IFNβ-1a (Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNβ-1b (Betaferon®) or fingolimod (Gilenya®) within 6 months prior to Visit 1 * Currently treated with Rebif using RebiSmart 2.0, for a maximum of 6 months prior to Visit 1 * Participants have a score on the Expanded Disability Status Scale (EDSS) between 0 to 5.0 inclusive * Participants willing and able to give informed consent. Exclusion Criteria: * Participants have known planned surgical procedures at the time of the informed consent that will prevent adherence to treatment with Rebif through RebiSmart 2.0 * Participants diagnosed with primary progressive, secondary progressive, or progressive relapsing MS * pregnant or lactating, or planning to become pregnant subjects * In the opinion of the Investigator has significant renal or hepatic impairment or other significant disease (e.g., cognitive or visual impairment) that would compromise adherence and completion of the study * Reports any reason that he/she cannot complete the 1 year study * Participants have a history of hypersensitivity to natural or recombinant interferon, or any other component of the formulation * Participants who contraindicated for the treatment with subcutaneous IFNβ-1a therapy as per summary of product characteristics or currently approved specific country product information * Participants have any other factor that in the opinion of the Investigator would make the subject unsuitable for participation in this study * Participants have significant psychiatric symptoms that, in the opinion of the Investigator, would impact patient ability to comply with treatment recommendations.

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

About this trial

In the sponsor's words

This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm study to measure treatment satisfaction of relapsing remitting MS (RRMS) participants on Rebif after discontinuing initial first-line treatment.

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History

    1. Started

      Feb 2017

    2. Main results due

      Aug 2017

    3. Finished

      Aug 2017

    4. Results posted

      Jan 2019

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