This trial is active, not recruiting.

Condition multiple sclerosis
Treatment interferon beta-1b (betaseron, bay86-5046)
Sponsor Bayer
Start date April 2012
End date December 2016
Trial size 1085 participants
Trial identifier NCT01491100, 16036, BF1101


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
interferon beta-1b (betaseron, bay86-5046)
Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants from 12 years up to 70 years old.

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.

Additional Information

Official title Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.