NCT02587065

Plegridy Satisfaction Study in Participants

Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Plegridy (Pre-filled Pen) in Subjects With Relapsing-remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	peginterferon beta-1a	125 mcg administered subcutaneously (SC) every 2 weeks.

Timeline

• Start date: 2016-02-03
• Primary completion: 2017-10-02
• Completion: 2017-12-21
• First posted: 2015-10-27
• Last updated: 2023-08-31
• Results posted: 2020-01-13

Locations

30 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study