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Plegridy Satisfaction Study in Participants

NCT ID: NCT02587065

Last Updated: 2023-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-03

Study Completion Date

2017-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Relapsing-Remitting Multiple Sclerosis (RRMS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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peginterferon beta-1a

125 μg administered subcutaneously (SC) every 2 weeks

Group Type EXPERIMENTAL

peginterferon beta-1a

Intervention Type DRUG

125 mcg administered subcutaneously (SC) every 2 weeks.

Interventions

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peginterferon beta-1a

125 mcg administered subcutaneously (SC) every 2 weeks.

Intervention Type DRUG

Other Intervention Names

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BIIB017 PEGylated Interferon Beta-1a Plegridy PEG IFN β-1a

Eligibility Criteria

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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.

Exclusion Criteria

* Pregnancy or breast-feeding.
* Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Arezzo, , Italy

Site Status

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Bari, , Italy

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Cagliari, , Italy

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Cefalù, , Italy

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Chieti, , Italy

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Como, , Italy

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Fidenza, , Italy

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Foligno, , Italy

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Gallarate, , Italy

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Genova, , Italy

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L’Aquila, , Italy

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Messina, , Italy

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Milan, , Italy

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Milan, , Italy

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Modena, , Italy

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Mondovì, , Italy

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Napoli, , Italy

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Napoli, , Italy

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Orbassano, , Italy

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Ozieri, , Italy

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Palermo, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Pietra Ligure, , Italy

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Pozzilli, , Italy

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Reggio Calabria, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Torino, , Italy

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Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-002201-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ITA-PEG-14-10779

Identifier Type: -

Identifier Source: org_study_id

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