Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 1 for:    NCT02230969
Previous Study | Return to List | Next Study

Plegridy Observational Program (POP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02230969
First received: August 29, 2014
Last updated: March 31, 2017
Last verified: March 2017
  Purpose
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 Intervention
Relapsing Forms of Multiple Sclerosis
Drug: peginterferon beta-1a

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Safety as measured by the incidence proportion of SAEs [ Time Frame: Up to 5 years ]
  • Safety as measured by the incidence rate of SAEs [ Time Frame: Up to 5 years ]
  • Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses [ Time Frame: Up to 5 years ]
  • Clinical NEDA as measured by the proportion of participants with no disability progression [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:
  • Prescription and utilization patterns as measured by prescribed dosing frequency [ Time Frame: Up to 5 years ]
  • Prescription and utilization patterns as measured by duration of Plegridy use [ Time Frame: Up to 5 years ]
  • Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy [ Time Frame: Up to 5 years ]
  • Relapse activity as measured by annualized relapse rate (ARR) [ Time Frame: Up to 5 years ]
  • Relapse activity as measured by time to first relapse [ Time Frame: Up to 5 years ]
  • Relapse activity as measured by the proportion of participants with relapse [ Time Frame: Up to 5 years ]
  • Relapse activity as measured by the distribution of the number of relapses [ Time Frame: Up to 5 years ]
  • 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.

  • Disability progression as measured by the time to sustained disability progression for at least six months [ Time Frame: Up to 5 years ]
  • Incidence proportion of non-serious AEs leading to treatment discontinuation [ Time Frame: Up to 5 years ]
  • Incidence rate of non-serious AEs leading to treatment discontinuation [ Time Frame: Up to 5 years ]
  • 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 ]
  • Changes in FLS assessment and FLS-VAS over time [ Time Frame: Baseline to 5 years ]
  • 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.

  • 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.

  • 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 ]

Enrollment: 1210
Study Start Date: November 2014
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02230969

  Show 193 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02230969     History of Changes
Other Study ID Numbers: 105MS401
Study First Received: August 29, 2014
Last Updated: March 31, 2017

Keywords provided by Biogen:
peginterferon
relapsing
pegylated
Subcutaneous
Injectable
Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 25, 2017