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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01491100
Other study ID # 16036
Secondary ID BF1101
Status Completed
Phase
First received December 12, 2011
Last updated April 4, 2018
Start date April 30, 2012
Est. completion date April 5, 2017

Study information

Verified date April 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1085
Est. completion date April 5, 2017
Est. primary completion date December 22, 2016
Accepts healthy volunteers No
Gender All
Age group 12 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Interferon beta-1b (Betaseron, BAY86-5046)
Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Albania,  Algeria,  Argentina,  Belgium,  Czechia,  Egypt,  France,  Germany,  Greece,  Hungary,  Israel,  Kazakhstan,  Netherlands,  Portugal,  Saudi Arabia,  Tunisia,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive performance as measured by SDMT (Symbol Digit Modalities Test) 24 months
Primary Physical activity as measured by the Baecke questionnaire 24 months
Secondary Disability as measured by EDSS (Expanded Disability Status Scale) 24 months
Secondary Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions) 24 months
Secondary Depression as measured by the CES-D (Center for Epidemiologic Studies Depression) 24 months
Secondary Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life) 24 months
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