check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

15098

ClinicalTrials.gov Identifier:

NCT01076595

EudraCT Number:

Not Available

EU CT Number:

Not Available
Prospective, multicenter non interventional study to evaluate adherence to betaferon over a 2 years period

Trial 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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - Contraindications and warning of the respective Summary of Product Characteristics

Trial summary

Enrollment Goal
73
Trial Dates
May 2010 - July 2014
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France

Primary Outcome

  • The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)
    date_rangeTime Frame:
    24 months
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    Safety Issue:
    no

Secondary Outcome

  • Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)
    date_rangeTime Frame:
    6 months, 12 months, 24 months
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    Safety Issue:
    no
  • Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)
    date_rangeTime Frame:
    6 months, 12 months
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    Safety Issue:
    no
  • Rate of patients with prematurely study discontinuation
    date_rangeTime Frame:
    0-6 months, 6-12 months, 12-18 months, 18-24 months
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    Safety Issue:
    No
  • Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)
    date_rangeTime Frame:
    24 months
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    Safety Issue:
    No
  • Tolerability of Betaferon injections (rate and number of injections)
    date_rangeTime Frame:
    24 months
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    Safety Issue:
    No
  • Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])
    date_rangeTime Frame:
    24 months
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    Safety Issue:
    No
  • Fatigue (mean total score of FSS [Fatigue Severity scale])
    date_rangeTime Frame:
    24 months
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    Safety Issue:
    No
  • Progression of clinical Condition( annual rate of Relapses)
    date_rangeTime Frame:
    24 months
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    Safety Issue:
    No
  • Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Prospective multicenter, non interventional study to evaluate the patient's characteristics associated with adherence to treatment regimen by betaferon in the BetaPlus program
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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