Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00928967

First received: June 23, 2009

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2009

Last Updated Date

January 24, 2012

Start Date ^ICMJE

May 2007

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evolution of the Daily Life score: Analysis of variance for repeated measurements. [ Time Frame: After 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00928967 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
Correlation coefficient with quality of life scales [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
Kinetics of treatment discontinuation: Kaplan Meier [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
Rate of treatment continuation [ Time Frame: After 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements. [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
Correlation coefficient with quality of life scales [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
Kinetics of treatment discontinuation: Kaplan Meier [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
Rate of treatment continuation [ Time Frame: After 12 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

Official Title ^ICMJE

Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS

Brief Summary

To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: None Retained

Description:

n.a.

Sampling Method

Non-Probability Sample

Study Population

Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria.The choice of treatment must be clearly dissociated from the decision to include the patient in the study.

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

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

The cohort included is described in section 8.5 (inclusion criteria)

Study Group/Cohort (s)

Group 1

Intervention: Drug: Interferon beta-1b, (Betaseron BAY86-5046)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria
The choice of treatment must be clearly dissociated from the decision to include the patient in the study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00928967

Other Study ID Numbers ^ICMJE

14168, Daily Life Study, BF0610FR

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Schering Pharma AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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