Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis

NCT01184833 | Completed

• 2 other identifiers: 14323BF0813PL
• Study Type: observational
• Target: 852
• Locations: 1 country
• Sites: 1

Brief Summary

Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients. Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures. This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Interferon beta-1b; Compliance to treatment; Premature treatment discontinuation

Outcome Measures

Primary Outcomes (1)

• Rate of discontinuation of Betaferon

  24 months

Secondary Outcomes (4)

• Number of missed doses of Betaferon

  24 months

• Depression score as measured by CES-D questionnaire

  24 months

• Neurological disability score as measured by EDSS scale

  24 months

• Overall tolerability of treatment as measured by rate of adverse events

  24 months

Study Arms (1)

Group 1

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

Interventions

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

Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.

Group 1

Eligibility Criteria

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

Study Population

Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.

You may qualify if:

• Relapsing-remitting multiple sclerosis
• Age \>/= 18 years

You may not qualify if:

• Synonymous with contraindications to Betaferon

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

MeSH Terms

Conditions

Multiple Sclerosis

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

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

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 19, 2010
• Study Start: September 1, 2008
• Study Completion: August 1, 2011
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

PL (1)