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 measurementsCorrelation 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
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