Clinical trial NCT02587065: Plegridy Satisfaction Study in Participants
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the Score of All Domains of TSQM-9 at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Change From Baseline in Annualized Relapse Rate (ARR) at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change in Relapse-Free Participants at Week 24
timeFrame: Baseline, Week 24
measure: Number of Participants With Adverse Events (AE)
timeFrame: Baseline up to Week 24
measure: Number of Participants With AE Stratified by Severity
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinical Abnormal Laboratory Values
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Cefalù
country: Italy
facility: Research Site
city: Chieti
country: Italy
facility: Research Site
city: Como
country: Italy
facility: Research Site
city: Fidenza
country: Italy
facility: Research Site
city: Foligno
country: Italy
facility: Research Site
city: Gallarate
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: L'Aquila
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Mondovì
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Ozieri
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pietra Ligure
country: Italy
facility: Research Site
city: Pozzilli
country: Italy
facility: Research Site
city: Reggio Calabria
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: