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Completed

NCT Number: NCT02230969

Plegridy Observational Program

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.

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Key information

Conditions

Relapsing Forms of Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon beta-1a

Drug

Administered as specified in the treatment arm

Other names: BIIB017, PEG IFN β-1a, Plegridy, PEGylated Interferon Beta-1a

Primary outcomes

  1. Safety as measured by the incidence proportion of SAEs

    Time frame: Up to 5 years

  2. Safety as measured by the incidence rate of SAEs

    Time frame: Up to 5 years

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

    Time frame: Up to 5 years

  4. Clinical NEDA as measured by the proportion of participants with no disability progression

    Time frame: Up to 5 years

Secondary outcomes

  1. Prescription and utilization patterns as measured by prescribed dosing frequency

    Time frame: Up to 5 years

  2. Prescription and utilization patterns as measured by duration of Plegridy use

    Time frame: Up to 5 years

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

    Time frame: Up to 5 years

  4. Relapse activity as measured by annualized relapse rate (ARR)

    Time frame: Up to 5 years

  5. Relapse activity as measured by time to first relapse

    Time frame: Up to 5 years

  6. Relapse activity as measured by the proportion of participants with relapse

    Time frame: Up to 5 years

  7. Relapse activity as measured by the distribution of the number of relapses

    Time frame: Up to 5 years

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

    Time frame: Up to 5 years

    Disability progression measured by the Expanded Disability Status Scale (EDSS). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who meet one of the following criteria: an increase of ≥ 1 point from baseline system score of ≥ 1 or an increase of ≥ 2 points from baseline system score of 0 in at least 2 physical functional systems, or an increase of ≥ 2 points from baseline system score of ≥ 1 or an increase of ≥ 3 points from baseline system score of 0 in any 1 physical functional system. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later.

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

    Time frame: Up to 5 years

  10. Incidence proportion of non-serious AEs leading to treatment discontinuation

    Time frame: Up to 5 years

  11. Incidence rate of non-serious AEs leading to treatment discontinuation

    Time frame: Up to 5 years

  12. Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS

    Time frame: Up to 5 years

  13. Changes in FLS assessment and FLS-VAS over time

    Time frame: Baseline to 5 years

  14. Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time

    Time frame: Baseline to 5 years

    The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

  15. Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires

    Time frame: Baseline to 5 years

    Where pen/syringe collection is locally allowed, treatment adherence will also be assessed by the proportion of used auto-injector pens/pre-filled syringes out of the total number of pens/syringes prescribed.

  16. Frequency of MS-related and non-MS-related physician visits, specialists' visits, use of physiotherapy, hospitalizations and lengths of stay, and emergency room/department visits

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program

Acronym: POP

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2014
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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