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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01076595
First received: February 25, 2010
Last updated: April 8, 2014
Last verified: April 2014
  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:
  • Patients characteristics associated with adherence to treatment regimen by Betaferon in the BetaPlus 6 months, 12 months, and 24 months after its initiation [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients characteristics associated with compliance [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Patients characteristics associated with self administration of Betaferon 6 months, 12 months and 24 months after its initiation. [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Quality of life of patients treated with Betaferon in the BetaPlus program [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • To gather observational data on Betaferon safety and tolerability. [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 74
Study Start Date: May 2010
Estimated Study Completion Date: April 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
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: April 8, 2014
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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 17, 2014