CompletedPhase 4Relapsing MSNCT022543042014-001290-14

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Percentage of Relapse-free RMS Subjects

Month 12

GroupValueIntervalNumber analysed
Rebif In RMS Subjects66.3 percentage of subjects89

Time to the First Relapse for CIS Subjects

Baseline up to 12 months

GroupValueIntervalNumber analysed
Rebif in CIS SubjectsNot reached17

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Rebif1061 (0.9%)

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

  • Percentage of Relapse-free RMS Subjects

    Month 12

    Relapses
  • Time to the First Relapse for CIS Subjects

    Baseline up to 12 months

    Relapses
  • Proportion of patients relapse free at 12 months of treatment at RMS subjects or time until the first relapse for CIS subjects.

    Relapses

Other measures (29)

  • Percentage of Subjects With Treatment Adherence

    Month 12

    Quality of life (reported by participants)
  • Percentage of Subjects With Relapse by Adherence Category

    Month 12

    RelapsesQuality of life (reported by participants)
  • Percentage of Subjects Who Prematurely Terminated Treatment and Reasons

    Baseline up to 12 months

  • Percentage of Subjects Free From Clinical Disease Activity

    Baseline up to 12 months

    Disability progression
  • Percentage of Subjects Free From Disability Progression

    Baseline up to 12 months

    Disability progression
  • Mean Number of Relapses in RMS Subjects

    Month 12

    Relapses
  • Number of Subjects With Reasons of Missed Injections

    Baseline up to 12 months

  • Overall Evaluation of RebiSmart Use as Assessed by Investigator

    Month 12

  • Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)

    Month 12

  • Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit

    Month 12

Who could take part

Relapsing MS · 18 to 65

Inclusion Criteria: * Male and female subjects between 18 to 65 years of age * Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol * Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010) * Treatment-naive subjects or subjects treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit * Subjects that are able to self-inject with RebiSmart™ (in the opinion of the physician) * Subjects with Expanded Disability Status Scale (EDSS) score less than (\<) 6 (inclusive) at Baseline * Signed informed consent and subject data collection form Exclusion Criteria: * Subjects experiencing a relapse within 30 days before Baseline * Participation in other studies within 30 days before Baseline * Received any MS therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™ * Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart™ * Pregnancy and breast-feeding * Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion * Current or past (within the last 2 years) history of alcohol or drug abuse * Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics

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 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).

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History

    1. Started

      Dec 2014

    2. Main results due

      Aug 2016

    3. Finished

      Aug 2016

    4. Results posted

      Mar 2018

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