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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01076595
First received: February 25, 2010
Last updated: January 14, 2015
Last verified: January 2015

February 25, 2010
January 14, 2015
May 2010
December 2013   (final data collection date for primary outcome measure)
The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01076595 on ClinicalTrials.gov Archive Site
  • Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%) [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Rate of patients with prematurely study discontinuation [ Time Frame: 0-6 months, 6-12 months, 12-18 months, 18-24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Tolerability of Betaferon injections (rate and number of injections) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis]) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Fatigue (mean total score of FSS [Fatigue Severity scale]) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Progression of clinical Condition( annual rate of Relapses) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period
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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

n.a

Non-Probability Sample

Outpatients

Multiple Sclerosis
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Betaferon 250 microgram
Group 1
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
July 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01076595
15098, BF0910FR
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP