NCT01491100

Brief Summary

Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,085

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
15 countries

15 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

December 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

April 30, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

4.6 years

First QC Date

December 12, 2011

Last Update Submit

April 4, 2018

Conditions

Multiple Sclerosis

Keywords

CognitionPhysical ActivityRelapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)

    24 months

  • Physical activity as measured by the Baecke questionnaire

    24 months

Secondary Outcomes (4)

  • Disability as measured by EDSS (Expanded Disability Status Scale)

    24 months

  • Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)

    24 months

  • Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)

    24 months

  • Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)

    24 months

Study Arms (1)

Group 1

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

Interventions

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

Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

Group 1

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

  • Patients with Relapsing Remitting Multiple Sclerosis (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician
  • EDSS 0 - 6
  • Written informed consent

You may not qualify if:

  • Patients who do not meet the local indication criteria for Betaferon treatment.
  • Contraindications listed in the local SmPCs have to be considered.
  • Patients with a history of severe head trauma.
  • Patients with alcohol and/or drug abuse.
  • Patients with mental retardation.
  • Patients with learning disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Multiple Locations, Albania

Location

Unknown Facility

Multiple Locations, Algeria

Location

Unknown Facility

Multiple Locations, Argentina

Location

Unknown Facility

Multiple Locations, Belgium

Location

Unknown Facility

Multiple Locations, Czechia

Location

Unknown Facility

Multiple Locations, Egypt

Location

Unknown Facility

Multiple Locations, France

Location

Unknown Facility

Multiple Locations, Germany

Location

Unknown Facility

Multiple Locations, Greece

Location

Unknown Facility

Multiple Locations, Hungary

Location

Unknown Facility

Multiple Locations, Israel

Location

Unknown Facility

Multiple Locations, Kazakhstan

Location

Unknown Facility

Multiple Locations, Netherlands

Location

Unknown Facility

Multiple Locations, Portugal

Location

Unknown Facility

Multiple Locations, Saudi Arabia

Location

Unknown Facility

Multiple Locations, Tunisia

Location

Unknown Facility

Multiple Locations, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisMotor ActivityMultiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

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

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
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 13, 2011

Study Start

April 30, 2012

Primary Completion

December 22, 2016

Study Completion

April 5, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

CZ(1)GR(1)AR(1)KA(1)FR(1)DE(1)AL(1)EG(1)NL(1)TU(1)HU(1)PT(1)BE(1)IL(1)SA(1)