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

Bayer67 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Unnamed facility

Many Locations, France

Outcomes

Primary Outcomes

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

Time frame: After 1, 3, 6, 9 and 12 months

Secondary Outcomes

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

Time frame: Over 12 months

Correlation coefficient with quality of life scales

Time frame: Over 12 months

Kinetics of treatment discontinuation: Kaplan Meier

Time frame: Over 12 months

Rate of treatment continuation

Time frame: After 12 months

Data from ClinicalTrials.gov

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