NCT03408093

Brief Summary

The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

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

Study Start

First participant enrolled

February 3, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2010

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

January 8, 2018

Last Update Submit

June 20, 2018

Conditions

Multiple Sclerosis

Keywords

Interferon beta-1b (INFb-1b)Multiple Sclerosis (MS)Relapsing-remitting MS (RRMS)Secondary progressive MS (SPMS)Clinically isolated syndrome (CIS)

Outcome Measures

Primary Outcomes (1)

  • Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test

    Four weeks just before baseline visit

Secondary Outcomes (9)

  • Demographic data

    At baseline

  • Number of patients with MS diagnosis

    At baseline

  • Age at first episode and at diagnosis

    At baseline

  • Time since last relapse

    At baseline

  • Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team

    At baseline

  • +4 more secondary outcomes

Study Arms (1)

Interferon beta-1b

Patients with CIS, RRMS or SPMS who had more than 6 months in treatment

Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)DRUG

Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.

Interferon beta-1b

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study included patients who had been on interferon beta-1b for more than 6 months and who agreed to participate in this study.

You may qualify if:

  • Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fernandez O, Aguera E, Izquierdo G, Millan-Pascual J, Ramio I Torrenta L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farres J; Group on Adherence to IFNb-1b in Spain. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One. 2012;7(5):e35600. doi: 10.1371/journal.pone.0035600. Epub 2012 May 16.

    PMID: 22615737RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

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

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 23, 2018

Study Start

February 3, 2009

Primary Completion

March 30, 2010

Study Completion

March 30, 2010

Last Updated

June 21, 2018

Record last verified: 2018-06