Clinical trial

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

Name

105MS401

Description

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.

Trial arms

Trial start

2014-11-12

Estimated PCD

2022-01-20

Trial end

2022-01-20

Status

Completed

Treatment

peginterferon beta-1a

Administered as specified in the treatment arm

Arms:

peginterferon beta-1a

Other names:

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

Size

1208

Primary endpoint

Safety as measured by the incidence proportion of SAEs

Up to 5 years

Safety as measured by the incidence rate of SAEs

Up to 5 years

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

Up to 5 years

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

Up to 5 years

Eligibility 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1208, 'type': 'ACTUAL'}}

Updated at

2022-09-26

1 organization

1 product

1 indication

Product

Peginterferon beta-1a

Indication

Multiple Sclerosis

Organization

Biogen