Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis (CogniPlus)

April 4, 2018 updated by: Bayer

Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1085

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)
Time Frame: 24 months
24 months
Physical activity as measured by the Baecke questionnaire
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disability as measured by EDSS (Expanded Disability Status Scale)
Time Frame: 24 months
24 months
Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)
Time Frame: 24 months
24 months
Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)
Time Frame: 24 months
24 months
Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2012

Primary Completion (ACTUAL)

December 22, 2016

Study Completion (ACTUAL)

April 5, 2017

Study Registration Dates

First Submitted

December 12, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (ESTIMATE)

December 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16036
  • BF1101 (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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