NCT02587065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 3, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

October 23, 2015

Results QC Date

October 16, 2019

Last Update Submit

August 18, 2023

Conditions

Relapsing-Remitting Multiple Sclerosis (RRMS)

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12

    TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit.

    Baseline, Week 12

Secondary Outcomes (10)

  • Change From Baseline in the Score of All Domains of TSQM-9 at Week 24

    Baseline, Week 24

  • Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24

    Baseline, Weeks 12 and 24

  • Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24

    Baseline, Weeks 12 and 24

  • Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24

    Baseline, Weeks 12 and 24

  • Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24

    Baseline, Weeks 12 and 24

  • +5 more secondary outcomes

Study Arms (1)

peginterferon beta-1a

EXPERIMENTAL

125 μg administered subcutaneously (SC) every 2 weeks

Drug: peginterferon beta-1a

Interventions

peginterferon beta-1aDRUG

125 mcg administered subcutaneously (SC) every 2 weeks.

Also known as: BIIB017, PEGylated Interferon Beta-1a, Plegridy, PEG IFN β-1a
peginterferon beta-1a

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria.
  • Subjects with EDSS score between 0.0 and 5.0 at baseline.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Research Site

Arezzo, 52100, Italy

Location

Research Site

Bari, 70124, Italy

Location

Research Site

Cagliari, 09126, Italy

Location

Research Site

Cefalù, 90015, Italy

Location

Research Site

Chieti, 66100, Italy

Location

Research Site

Como, 22100, Italy

Location

Research Site

Fidenza, 43036, Italy

Location

Research Site

Foligno, 06034, Italy

Location

Research Site

Gallarate, 21013, Italy

Location

Research Site

Genova, 16132, Italy

Location

Research Site

L’Aquila, 67100, Italy

Location

Research Site

Messina, 98125, Italy

Location

Research Site

Milan, 20132, Italy

Location

Research Site

Milan, 20133, Italy

Location

Research Site

Modena, 41126, Italy

Location

Research Site

Mondovì, 12084, Italy

Location

research Site

Napoli, 80131, Italy

Location

Research Site

Napoli, 80137, Italy

Location

Research Site

Orbassano, 10043, Italy

Location

Research Site

Ozieri, 07014, Italy

Location

Research Site

Palermo, 90129, Italy

Location

Research Site

Palermo, 90146, Italy

Location

Research Site

Pavia, 27100, Italy

Location

Research Site

Pietra Ligure, 17027, Italy

Location

Research Site

Pozzilli, 86077, Italy

Location

Research Site

Reggio Calabria, 89100, Italy

Location

Research Site

Roma, 00152, Italy

Location

Research Site

Roma, 00168, Italy

Location

Research Site

Roma, 00189, Italy

Location

Research Site

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

peginterferon beta-1a

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Biogen Study Medical Director
Organization
Biogen
clinicaltrials@biogen.com
866-633-4636

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 27, 2015

Study Start

February 3, 2016

Primary Completion

October 2, 2017

Study Completion

December 21, 2017

Last Updated

August 31, 2023

Results First Posted

January 13, 2020

Record last verified: 2023-08

Locations

IT(30)