Clinical trial NCT01076595: Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period
Official title: Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
BetaPlus program
Recurrent/remittent multiple sclerosis patients
Adherence to treatment regimen
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients

Brief summary: The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program


Eligibility criteria: Inclusion Criteria:

* Male or female \>/= 18 years old
* Outpatient with a confirmed diagnosis of Recurrent-Remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event
* Patient who initiated Betaferon as described by SmPC less than 2 months ago. The decision of physician is clearly separated from the decision to include the patient in the study
* Treatment naïve patients before the initiation of Betaferon
* OR Patients having interrupted Betaferon for more than 6 months before to start again
* OR Patients receiving a disease modifying drug (DMD) other than Betaferon
* Patient with EDSS score \< 4
* Patients approved and signed an inform consent and approved the collect of their data

Exclusion Criteria:

* Contraindications and warning of the respective Summary of Product Characteristics

Primary outcomes:
measure: The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)
timeFrame: 24 months
Secondary outcomes:
measure: Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)
timeFrame: 6 months, 12 months, 24 months
measure: Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)
timeFrame: 6 months, 12 months
measure: Rate of patients with prematurely study discontinuation
timeFrame: 0-6 months, 6-12 months, 12-18 months, 18-24 months
measure: Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)
timeFrame: 24 months
measure: Tolerability of Betaferon injections (rate and number of injections)
timeFrame: 24 months
measure: Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])
timeFrame: 24 months
measure: Fatigue (mean total score of FSS [Fatigue Severity scale])
timeFrame: 24 months
measure: Progression of clinical Condition( annual rate of Relapses)
timeFrame: 24 months
measure: Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study
timeFrame: 24 months
measure: Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24
timeFrame: 24 months
Other outcomes:
Locations:
city: Many Locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: