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

July 2, 2015 updated by: Bayer

Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Many Locations, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Betaferon 250 microgram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)
Time Frame: 24 months
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (ESTIMATE)

February 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15098
  • BF0910FR (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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