POP
We could not find results for this trial
I know where the results areWhat it 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
- Peginterferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
Safety as measured by the incidence proportion of SAEs
Up to 5 years
SafetySafety as measured by the incidence rate of SAEs
Up to 5 years
SafetyClinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
Up to 5 years
RelapsesClinical 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
RelapsesRelapse activity as measured by time to first relapse
Up to 5 years
RelapsesRelapse activity as measured by the proportion of participants with relapse
Up to 5 years
RelapsesRelapse activity as measured by the distribution of the number of relapses
Up to 5 years
RelapsesDisability progression as measured by the proportion of participants with sustained progression for at least six months
Up to 5 years
Disability progressionDisability progression as measured by the time to sustained disability progression for at least six months
Up to 5 years
Disability progressionIncidence 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
Loading reviews and guidelines…
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History
Started
Nov 2014
Main results due
Jan 2022
Finished
Jan 2022
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