Physical Activity and Fatigue in Early Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— BEGIN  

Official title:

Betaferon Treatment and Exercise Data Gathering IN Early MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882453
• Other study ID #: 13853
• Secondary ID: BF0601310721
• Status: Completed
• Phase: N/A
• First received: April 15, 2009
• Last updated: May 28, 2012
• Start date: August 2006
• Est. completion date: March 2011

Study information

• Verified date: May 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeBelgium: Ethics CommitteeCanada: Ethics Review CommitteeCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Comité National de l'Ordre des Médecins = CNOMGermany: Federal Institute for Drugs and Medical DevicesGreece: Ethics CommitteeGreece: National Organization of MedicinesIsrael: Ethics CommissionItaly: Ethics CommitteeKazakhstan: National Center for Expertise of Medicinal DrugsLebanon: Institutional Review BoardMexico: Ethics CommitteeNorway:National Committee for Medical and Health Research EthicsPortugal: National Committee for Data Protection (CNPD)Portugal: Health Ethic CommitteePortugal: National Pharmacy and Medicines InstituteSouth Korea: Korea Food and Drug Administration (KFDA)Slovenia: Ethics CommitteeSlovenia: Agency for Medicinal Products - Ministry of HealthSpain: Regional Health AuthoritiesSpain: Ethics CommitteeSpain: Spanish Agency of MedicinesSweden: Regional Ethical Review BoardTaiwan: Institutional Review BoardTaiwan: Local Ethics CommitteesThailand: Ethical CommitteeUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1739
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Multiple sclerosis diagnosed within the last 12 months

• Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Intravenous therapy according to product information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity and Fatigue		At baseline and at Month 24	No
Secondary	Health-related Quality of Life		At baseline and at Month 24	No
Secondary	Depression		At baseline and at Month 24	No

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