Trial Condition(s):

Multiple Sclerosis

Prospective, multicenter non interventional study to evaluate adherence to betaferon over a 2 years period (SEPLUS)

Bayer Identifier:

15098

ClinicalTrials.gov Identifier:

NCT01076595

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
73
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Completed
 

Trial Design