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

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ClinicalTrials.gov Identifier: NCT01076595
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Design
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Study Type : Observational
Actual Enrollment : 73 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : July 2014

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Betaferon 250 microgram


Outcome Measures
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Primary Outcome Measures :
  1. The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%) [ Time Frame: 6 months, 12 months, 24 months ]
  2. Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months) [ Time Frame: 6 months, 12 months ]
  3. Rate of patients with prematurely study discontinuation [ Time Frame: 0-6 months, 6-12 months, 12-18 months, 18-24 months ]
  4. 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 ]
  5. Tolerability of Betaferon injections (rate and number of injections) [ Time Frame: 24 months ]
  6. Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis]) [ Time Frame: 24 months ]
  7. Fatigue (mean total score of FSS [Fatigue Severity scale]) [ Time Frame: 24 months ]
  8. Progression of clinical Condition( annual rate of Relapses) [ Time Frame: 24 months ]
  9. Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study [ Time Frame: 24 months ]
  10. Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24 [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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France
Many Locations, France
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01076595    
Other Study ID Numbers: 15098
BF0910FR ( Other Identifier: company internal )
First Posted: February 26, 2010    Key Record Dates
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:
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Multiple Sclerosis
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