CompletedRelapsing MSNCT02230969

We could not find results for this trial

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What it found

No result found

We found no results in the registry or in papers.

This trial finished 4 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

  • Safety as measured by the incidence proportion of SAEs

    Up to 5 years

    Safety
  • Safety as measured by the incidence rate of SAEs

    Up to 5 years

    Safety
  • Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses

    Up to 5 years

    Relapses
  • Clinical NEDA as measured by the proportion of participants with no disability progression

    Up to 5 years

    Disability progression

Other measures (16)

  • Prescription and utilization patterns as measured by prescribed dosing frequency

    Up to 5 years

  • Prescription and utilization patterns as measured by duration of Plegridy use

    Up to 5 years

  • Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy

    Up to 5 years

  • Relapse activity as measured by annualized relapse rate (ARR)

    Up to 5 years

    Relapses
  • Relapse activity as measured by time to first relapse

    Up to 5 years

    Relapses
  • Relapse activity as measured by the proportion of participants with relapse

    Up to 5 years

    Relapses
  • Relapse activity as measured by the distribution of the number of relapses

    Up to 5 years

    Relapses
  • Disability progression as measured by the proportion of participants with sustained progression for at least six months

    Up to 5 years

    Disability progression
  • Disability progression as measured by the time to sustained disability progression for at least six months

    Up to 5 years

    Disability progression
  • Incidence proportion of non-serious AEs leading to treatment discontinuation

    Up to 5 years

Who could take part

Relapsing MS · 18 and over

Key Inclusion Criteria: * Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002). * Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance. Key Exclusion Criteria: * Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol. 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 objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

Papers

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    Linked trials

    • Refers to

      ALLOW

      Phase 3 · Completed

    • Refers to

      ATTAIN

      Phase 3 · Completed

    Links found where a registry record names another trial's registry number.

    Related trials

    History

      1. Started

        Nov 2014

      2. Main results due

        Jan 2022

      3. Finished

        Jan 2022

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