Plegridy Satisfaction Study in Participants

• Status: Completed
• Trial end date: 2017-12-21
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants' satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants' adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on participants' injection-system satisfaction; Evaluate the relationship between participants' satisfaction and adherence; Evaluate the relationship between participants' satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate the treatment safety and tolerability.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Key Inclusion Criteria:

• Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria.

• Subjects with EDSS score between 0.0 and 5.0 at baseline.

Key Exclusion Criteria:

• Pregnancy or breast-feeding.

• Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.