Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bayer Identifier:
First received: December 12, 2011
Last updated: October 17, 2016
Last verified: October 2016
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 ]

Enrollment: 1085
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.


Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01491100

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

Additional Information:
Responsible Party: Bayer Identifier: NCT01491100     History of Changes
Other Study ID Numbers: 16036  BF1101 
Study First Received: December 12, 2011
Last Updated: October 17, 2016
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:
Physical Activity
Relapsing Remitting Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on January 17, 2017