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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491100
First Posted: December 13, 2011
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 ]
  • Physical activity as measured by the Baecke questionnaire [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Disability as measured by EDSS (Expanded Disability Status Scale) [ Time Frame: 24 months ]
  • Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions) [ Time Frame: 24 months ]
  • Depression as measured by the CES-D (Center for Epidemiologic Studies Depression) [ Time Frame: 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 ]

Enrollment: 1085
Actual Study Start Date: April 30, 2012
Study Completion Date: April 5, 2017
Primary Completion Date: December 22, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491100


  Show 17 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01491100     History of Changes
Other Study ID Numbers: 16036
BF1101 ( Other Identifier: company internal )
First Submitted: December 12, 2011
First Posted: December 13, 2011
Last Update Posted: May 25, 2017
Last Verified: May 2017

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

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