Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01491100
First received: December 12, 2011
Last updated: November 18, 2014
Last verified: November 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
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 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: November 18, 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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta-1b
Interferon-beta
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014