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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT01076595
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Study Start: 2010-05
• Primary Completion: 2013-11
• Study Completion: 2014-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-02
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

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Exclusion Criteria

• Contraindications and warning of the respective Summary of Product Characteristics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)	6 months, 12 months, 24 months
Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)	6 months, 12 months
Rate of patients with prematurely study discontinuation	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)	24 months
Tolerability of Betaferon injections (rate and number of injections)	24 months
Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])	24 months
Fatigue (mean total score of FSS [Fatigue Severity scale])	24 months
Progression of clinical Condition( annual rate of Relapses)	24 months
Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study	24 months
Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24	24 months