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Plegridy Observational Program (POP)

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ClinicalTrials.gov Identifier: NCT02230969
Recruitment Status : Active, not recruiting
First Posted : September 3, 2014
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Relapsing Forms of Multiple Sclerosis Drug: peginterferon beta-1a

Study Design
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Study Type : Observational
Actual Enrollment : 1210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program
Actual Study Start Date : November 12, 2014
Estimated Primary Completion Date : January 20, 2022
Estimated Study Completion Date : January 20, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
peginterferon beta-1a
Plegridy will not be supplied for this study. The study will collect data in an observational manner from participants who are prescribed Plegridy by physicians, according to the approved label in the respective country.
 Drug: peginterferon beta-1a
Administered as specified in the treatment arm
Other Names:
  • BIIB017
  • PEG IFN β-1a
  • Plegridy
  • PEGylated Interferon Beta-1a


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted in participants with relapsing forms of MS who are newly or currently prescribed Plegridy as prescribed under routine clinical practice and participants who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002).
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230969


Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02230969    
Other Study ID Numbers: 105MS401
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Keywords provided by Biogen:
peginterferon
relapsing
pegylated
 Subcutaneous
Injectable
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic