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

NCT01076595 | Completed

• 2 other identifiers: 15098BF0910FR
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; BetaPlus program; Recurrent/remittent multiple sclerosis patients; Adherence to treatment regimen

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (10)

• Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)

  6 months, 12 months, 24 months

• Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)

  6 months, 12 months

• Rate of patients with prematurely study discontinuation

  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)

  24 months

• Tolerability of Betaferon injections (rate and number of injections)

  24 months

Study Arms (1)

Group 1

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

Interventions

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

Betaferon 250 microgram

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients

You may qualify if:

• 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

You may not qualify if:

• Contraindications and warning of the respective Summary of Product Characteristics

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: July 1, 2014
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

FR (1)