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

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ClinicalTrials.gov Identifier: NCT01491100
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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

Study Type : Observational
Actual Enrollment : 1085 participants
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®
Actual Study Start Date : April 30, 2012
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : April 5, 2017


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.



Primary Outcome Measures :
  1. Cognitive performance as measured by SDMT (Symbol Digit Modalities Test) [ Time Frame: 24 months ]
  2. Physical activity as measured by the Baecke questionnaire [ Time Frame: 24 months ]

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


Information from the National Library of Medicine

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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.

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01491100     History of Changes
Other Study ID Numbers: 16036
BF1101 ( Other Identifier: company internal )
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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