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

NCT ID: NCT01076595

Last Updated: 2015-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Intervention Type DRUG

Betaferon 250 microgram

Interventions

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

Betaferon 250 microgram

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , France

Site Status

Countries

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France

Other Identifiers

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BF0910FR

Identifier Type: OTHER

Identifier Source: secondary_id

15098

Identifier Type: -

Identifier Source: org_study_id

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