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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

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

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Clinical Details

Official title: 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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Evolution of the Daily Life score: Analysis of variance for repeated measurements.

Secondary outcome:

Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements

Correlation coefficient with quality of life scales

Kinetics of treatment discontinuation: Kaplan Meier

Rate of treatment continuation

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Many Locations, France
Additional Information

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Starting date: May 2007
Last updated: January 24, 2012

Page last updated: August 20, 2015

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