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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01491100
First received: December 12, 2011
Last updated: April 14, 2014
Last verified: April 2014
  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: Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®

Resource links provided by NLM:


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: 1300
Study Start Date: April 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (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:

  • 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.
  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 24 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01491100     History of Changes
Other Study ID Numbers: 16036, BF1101
Study First Received: December 12, 2011
Last Updated: April 14, 2014
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 April 15, 2014