Plegridy Satisfaction Study in Participants (PLATINUM)

Biogen

Status and phase: Completed; Phase 4

Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)

Treatments: Drug: peginterferon beta-1a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02587065

2015-002201-11 (EudraCT Number)

ITA-PEG-14-10779

Details and patient eligibility

About

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.

Enrollment: 193 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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193 participants in 1 patient group

peginterferon beta-1a

Experimental group

Description:

125 μg administered subcutaneously (SC) every 2 weeks

Treatment:

Drug: peginterferon beta-1a