Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period

Bayer73 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Interventions

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

Betaferon 250 microgram

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Many Locations, France

Outcomes

Primary Outcomes

The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)

Time frame: 24 months

Secondary Outcomes

Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)

Time frame: 6 months, 12 months, 24 months

Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)

Time frame: 6 months, 12 months

Rate of patients with prematurely study discontinuation

Time frame: 0-6 months, 6-12 months, 12-18 months, 18-24 months

Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)

Time frame: 24 months

Tolerability of Betaferon injections (rate and number of injections)

Time frame: 24 months

Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])

Time frame: 24 months

Fatigue (mean total score of FSS [Fatigue Severity scale])

Time frame: 24 months

Progression of clinical Condition( annual rate of Relapses)

Time frame: 24 months

Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study

Data from ClinicalTrials.gov

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