Physical Activity and Fatigue in Early Multiple Sclerosis... | NCT00882453

Studies
Physical Activity and Fatigue in Early Multiple Sclerosis (MS)

NCT00882453

Sponsor

Bayer

Status

Completed

Last Update Posted

May 30, 2012Estimated

Enrollment

1,739Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

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

Countries

Australia
Austria
Bahrain
Belgium
Canada
Colombia
Czechia
Denmark
Egypt
France
Germany
Greece
Indonesia
Israel
Italy
Jordan
Kazakhstan
Kuwait
Lebanon
Mexico
Netherlands
Norway
Oman
Portugal
Slovenia
South Korea
Spain
Sweden
Switzerland
Taiwan
Thailand
United Arab Emirates
United Kingdom

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
BF0601	Other Identifier	company internal
310721	Other Identifier	company internal

Status Module

Record Verification Date

May 2012

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

Aug 2006

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Apr 15, 2009

First Submission Date that Met QC Criteria

Apr 15, 2009

First Posted Date

Apr 16, 2009Estimated

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

May 28, 2012

Last Update Posted Date

May 30, 2012Estimated

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

Description Module

Brief Summary

The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

Detailed Description

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

1,739Actual

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	Intravenous therapy according to product information	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical Activity and Fatigue		At baseline and at Month 24

Secondary Outcomes

Measure	Description	Time Frame
Health-related Quality of Life		At baseline and at Month 24
Depression		At baseline and at Month 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Multiple sclerosis diagnosed within the last 12 months
Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients after a first demyelinating event suggestive of MS as well as patients with recently diagnosed RRMS (< 12 months)

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

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D009043	Motor Activity
D005221	Fatigue

Ancestor Terms

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
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Facility	Status	City	State	ZIP	Country	Contacts
		Many Locations			Australia

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