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

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01491100
First received: December 12, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Multiple Sclerosis
 Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognition Plus Physical Activity Assessed in Patients With Multiple Sclerosis, Treated With Betaferon

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cognitive performance as measured by SDMT (Symbol Digit Modalities Test) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Physical activity as measured by the Baecke questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability as measured by EDSS (Expanded Disability Status Scale) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Depression as measured by the CES-D (Center for Epidemiologic Studies Depression) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community Sample

Criteria

Inclusion Criteria:

  • Disease duration ≤10 years
  • EDSS (Expanded Disability Status Scale) ≤ 5
  • Patients able to walk
  • Treatment with Betaferon according to indication

Exclusion Criteria:

  • Betaferon contraindications
  • Alcohol or Drug Abuse
  • Learning Disability
  • Mental Retardation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491100

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 22 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01491100     History of Changes
Other Study ID Numbers: 16036, BF1101
Study First Received: December 12, 2011
Last Updated: May 15, 2013
Health Authority: Albania: National Bioethics Committee, Ministry of Health Department of Pharmacy
Algeria: Ministry of Health
Argentina: Comité Independiente de Ética para Ensayos en Farmacología Clínica
Belgium: Ethics Committee
Bosnia: Agency for Medicinal Products and Medicinal Devices of Bosnia and Herzegovina
Czech Republic: State Institute for Drug Control
Egypt: Ministry of Health and Population
France: The Commission nationale de l’informatique et des libertés
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Hungary: Scientific and Medical Research Council Ethics Committee
Israel: Israeli Health Ministry Pharmaceutical Administration
Kazakhstan: National Center for Expertise of Drugs, Medical Products and Equipment
Netherlands: Medical Ethics Review Committee (METC)
Portugal: National Authority of Medicines and Health Products, National Committee for Data Protection
Saudi Arabia: Saudi Food & Drug Authority
Tunisia: Office of Pharmacies and Medicines
Turkey: Ministry of Health

Keywords provided by Bayer:
Cognition
Physical Activity
Relapsing Remitting Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 19, 2013