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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:
Bayer
ClinicalTrials.gov Identifier:
NCT01076595
First received: February 25, 2010
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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: February 2014
Estimated Primary Completion Date: February 2014 (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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01076595     History of Changes
Other Study ID Numbers: 15098, BF0910FR
Study First Received: February 25, 2010
Last Updated: April 18, 2013
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 May 16, 2013