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
  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


Condition Intervention
Multiple Sclerosis
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 73
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Betaferon 250 microgram

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076595

Locations
France
Many Locations, France
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01076595     History of Changes
Other Study ID Numbers: 15098, BF0910FR
Study First Received: February 25, 2010
Last Updated: January 14, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bayer:
Multiple sclerosis
BetaPlus program
Recurrent/remittent multiple sclerosis patients
Adherence to treatment regimen

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta-1b
Interferon-beta
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2015