NCT03577977

Brief Summary

The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2009

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

June 25, 2018

Last Update Submit

July 10, 2018

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis (MS), Betaseron, Betaferon

Outcome Measures

Primary Outcomes (10)

  • Mean expanded disability status scale (EDSS) score at the end of trial participation

    The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.

    Up to 2 years

  • Proportion of patients having the mean EDSS score of less than or equal to 3.0 and more than or equal to 3.5 at the end of the trial

    The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.

    Up to 2 years

  • Mean frequency of complications recorded after start of betaferon therapy

    Up to 2 years

  • Mean EDSS score on the exacerbations recorded after start of betaferon therapy

    The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.

    Up to 2 years

  • Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug

    Up to 2 years

  • Number of mild, moderate, or severe adverse events

    Up to 2 years

  • Number of serious adverse events described during the trial

    Up to 2 years

  • Number of adverse events described during the trial and classified as an flu-like syndrome

    Up to 2 years

  • Number of adverse events described during the trial and classified as a local reaction

    Up to 2 years

  • Number of cases of betaferon discontinuation due to adverse events

    Up to 2 years

Study Arms (1)

Patients treated with Betaferon

Patients with very early onset of MS, who received at least one injection of interferon beta-1b as prescribed by the treating physician, before the age of 18.

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

Interventions

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

Betaferon was injected subcutaneously as prescribed by the treating physician.

Patients treated with Betaferon

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Multiple sclerosis patients under 18 years old treated with at least one dose of Betaferon until 31.12.2007.

You may qualify if:

  • patients with symptoms consistent with the diagnosis of a demyelinating CNS disease
  • patients who received at least one injection of Betaferon before age 18 (before their 18th birthday)
  • recorded use of at least one dose of Betaferon before January 1, 2008

You may not qualify if:

  • Diagnosis other then MS or a demyelinating CNS disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Russia

Location

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
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 5, 2018

Study Start

June 1, 2008

Primary Completion

April 15, 2009

Study Completion

April 15, 2009

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

RU(1)