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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01491100
• Date of registration: 12/12/2011
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis CogniPlus
• Scientific title: Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®
• Date of first enrolment: April 30, 2012
• Target sample size: 1085
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01491100
• Study type: Observational

Countries of recruitment

Albania, Algeria, Argentina, Belgium, Bosnia and Herzegovina, Czech Republic, Czechia, Egypt, France, Germany, Greece, Hungary, Israel, Jordan, Kazakhstan, Lebanon, Mexico, Netherlands, Poland, Portugal, Saudi Arabia, Syrian Arab Republic, Tunisia, Turkey

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Primary Outcome(s)

Physical activity as measured by the Baecke questionnaire [Time Frame: 24 months]

Cognitive performance as measured by SDMT (Symbol Digit Modalities Test) [Time Frame: 24 months]

Secondary Outcome(s)

Disability as measured by EDSS (Expanded Disability Status Scale) [Time Frame: 24 months]

Depression as measured by the CES-D (Center for Epidemiologic Studies Depression) [Time Frame: 24 months]

Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions) [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]

Secondary ID(s)

16036

BF1101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors