Noninterventional Study Assessing Cognitive Function and... | NCT01491100

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

NCT01491100

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 5, 2018Actual

Enrollment

1,085Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

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

Countries

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

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
BF1101	Other Identifier	company internal

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2012Actual

Primary Completion Date

Dec 22, 2016Actual

Completion Date

Apr 5, 2017Actual

First Submitted Date

Dec 12, 2011

First Submission Date that Met QC Criteria

Dec 12, 2011

First Posted Date

Dec 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,085Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon beta-1b (Betaseron, BAY86-5046)	Drug	Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)		24 months
Physical activity as measured by the Baecke questionnaire		24 months

Secondary Outcomes

Measure	Description	Time Frame
Disability as measured by EDSS (Expanded Disability Status Scale)		24 months
Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Community Sample

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Bosnia and Herzegovina
Jordan
Lebanon
Mexico
Poland
Syria

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Facility	Status	City	State	ZIP	Country	Contacts
		Multiple Locations			Albania

ID	Term
D009103	Multiple Sclerosis
D009043	Motor Activity
D020529	Multiple Sclerosis, Relapsing-Remitting

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D001519	Behavior

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors