Overview

Plegridy Observational Program

Status:
Active, not recruiting
Trial end date:
2022-01-20
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Treatments:
Interferon beta-1a
Interferon-beta
Interferons
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