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MAIN-MS

A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With RMS Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a (MAIN-MS)
CompletedRelapsing MSNCT02921035

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

What it measured

Main measures

  • Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score

    Month 24

    Quality of life (reported by participants)

Other measures (7)

  • Percentage of subjects on Rebif who discontinued the treatment

    up to 24 months

  • Time to treatment discontinuation

    up to 24 months

  • Reason for treatment discontinuation

    up to 24 months

    Safety

  • Percentage of relapse-free subjects

    Month 24

    Relapses

  • Percentage of subjects with expanded disability status scale (EDSS) progression

    Month 24

    Disability progression

  • Number of subjects with suspected adverse drug reactions (ADRs) related to Rebif treatment and concomitant therapy over the 24 months of the study

    Up to 24 months

  • Percentage of relapse-free subjects based on MGLS Score

    Up to 24 month

    Relapses

Who could take part

Relapsing MS · 18 to 60

Inclusion Criteria: * Male and female subjects aged more than or equal to (>=) 18 years and less than or equal to (\<=) 60 years at the time of Rebif introduction * Subjects diagnosed with RMS according to the revised McDonald criteria (2010) * Treatment naïve or subjects on other DMDs who will switch to Rebif. * Subjects will receive 1st Rebif 44 mcg dose after signing informed consent * Subjects willing and able to provide signed informed consent. Exclusion Criteria: * Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information * Subjects participating in other clinical studies/trials * Any female subject of childbearing potential who is not on contraceptives * Subjects refusal to participate in the study.

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

About this trial

In the sponsor's words

This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 months.

Papers

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Related trials

History

    1. Started

      Jun 2016

    2. Main results due

      Jul 2020

    3. Finished

      Jul 2020

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