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

Multiple Sclerosis Clinical Trial

— SEPLUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076595
• Other study ID #: 15098
• Secondary ID: BF0910FR
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: July 2, 2015
• Start date: May 2010
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Betaferon 250 microgram

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)		24 months	No
Secondary	Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)		6 months, 12 months, 24 months	No
Secondary	Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)		6 months, 12 months	No
Secondary	Rate of patients with prematurely study discontinuation		0-6 months, 6-12 months, 12-18 months, 18-24 months	No
Secondary	Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)		24 months	No
Secondary	Tolerability of Betaferon injections (rate and number of injections)		24 months	No
Secondary	Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])		24 months	No
Secondary	Fatigue (mean total score of FSS [Fatigue Severity scale])		24 months	No
Secondary	Progression of clinical Condition( annual rate of Relapses)		24 months	No
Secondary	Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study		24 months	No
Secondary	Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24		24 months	No

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