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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076595
First Posted: February 26, 2010
Last Update Posted: July 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 ]

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

Biospecimen Retention:   None Retained
n.a

Enrollment: 73
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: November 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076595


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01076595     History of Changes
Other Study ID Numbers: 15098
BF0910FR ( Other Identifier: company internal )
First Submitted: February 25, 2010
First Posted: February 26, 2010
Last Update Posted: July 3, 2015
Last Verified: July 2015

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

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