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Completed

NCT Number: NCT01076595

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon beta-1b (Betaseron, BAY86-5046)

Drug

Betaferon 250 microgram

Primary outcomes

  1. The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program

Acronym: SEPLUS

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Feb 26, 2010
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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