NCT01272128

Brief Summary

The primary objective is to assess the quality of life of intramuscular (IM) Interferon Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) in a clinical practice setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

17 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

January 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

January 6, 2011

Last Update Submit

October 16, 2015

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months

    Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.

    Baseline and Month 12

Secondary Outcomes (6)

  • Change from Baseline in EQ-5D VAS at 6, 18 and 24 months

    Baseline and Months 6, 18 and 24

  • Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score

    Baseline and Months 6, 12, 18 and 24

  • Change from Baseline in EQ-5D Summary Score

    Baseline and Months 6, 12, 18 and 24

  • Convenience

    Baseline and Months 6, 12, 18 and 24

  • Correlation between VAS and MSIS29

    Baseline and Months 6, 12, 18 and 24

  • +1 more secondary outcomes

Interventions

Interferon beta-1aDRUG

Interferon beta-1a will not be provided as a part of this study. Participants will receive Interferon beta-1a as prescribed by their treating physician prior to enrollment.

Also known as: BG9418, Avonex Pen, Avonex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) who meet the criteria for prescription of Interferon Beta-1a IM at up to 20 Belgian institutions may participate into this study.

You may qualify if:

  • Decision to treat with Interferon Beta-1a (IFN beta-1a) must precede enrollment, independently of the study and in compliance with the marketing authorization
  • Study enrollment must occur prior to 4th weekly administration of IFN beta-1a
  • Able to understand and complete a self-administered questionnaire
  • No contra-indications for IFN beta-1a

You may not qualify if:

  • Subjects with history of hypersensitivity to natural or recombinant IFN beta or to any component
  • Subjects with primary or secondary progressive MS
  • Subjects with current severe depression and/or suicidal ideation
  • Pregnant women
  • Subjects participating in another clinical trial
  • Subjects who do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Research Site

Bonheiden, Antwerp, 2820, Belgium

Location

Research Site

Middelheim, Antwerp, 2020, Belgium

Location

Research Site

Ottignies, Brabant Wallon, 1340, Belgium

Location

Research Site

Woluwe, Brussels Capital, 1200, Belgium

Location

Research Site

Aalst, East Flanders, 9300, Belgium

Location

Research Site

Saint Niklaas, East Flanders, 9100, Belgium

Location

Research Site

Tielt, East Flanders, 8700, Belgium

Location

Research Site

Baudour, Hainaut, 7331, Belgium

Location

Research Site

Charleroi, Hainaut, 6000, Belgium

Location

Research Site

Charleroi, Hainaut, 6042, Belgium

Location

Research Site

La Louvière, Hainaut, 7100, Belgium

Location

Research Site

Tournai, Hainaut, 7500, Belgium

Location

Research Site

Hasselt, Limburg, 3500, Belgium

Location

Research Site

Liège, Liège, 4000, Belgium

Location

Research Site

Verviers, Liège, 4800, Belgium

Location

Research Site

Libramont, Luxembourg, 6800, Belgium

Location

Research Site

Sijsele, West Flanders, 8340, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 7, 2011

Study Start

December 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

BE(17)