Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)

Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)

Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.

Study Overview

• Status: Completed
• Conditions: Relapsing-Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Interferon beta-1b (Betaseron, BAY86-5046); Drug: Interferon beta-1b (Betaseron, BAY86-5046); Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Study Type: Observational
• Enrollment (Actual): 702

Contacts and Locations

Study Locations

• Germany
  • Many Locations, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult female and male Clinically Isolated Syndrome (CIS) and relapsing-remitting multiple sclerosis (RRMS) patients who are at least 18 years of age, have started a treatment with Betaferon based on clinical decision by the treating neurologist and have completed the dose titration, will be documented after the therapy decision has been made.

The prescription of the medicine must be clearly independent from the decision to include the patient in the study.

Description

Inclusion Criteria:

• Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study.

Exclusion Criteria:

• Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.
• Exclusion criteria must be read in conjunction with the German product information.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder; Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder; Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon)
Group 2	Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder; Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder; Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon)
Group 3	Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder; Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder; Drug: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaferon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Drop out rate over 2 years	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Disability status	After 3, 6, 12 and 24 months
Grade of depressiveness	After 3, 6, 12 and 24 months
Grade of fatigue	After 3, 6, 12 and 24 months
Quality of life	After 3, 6, 12 and 24 months
Cognitive status	After 12 and 24 months
Injection regularity	After 3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Hecker M; Study Group. Comparative evaluation of patients' and physicians' satisfaction with interferon beta-1b therapy. BMC Neurol. 2016 Sep 21;16(1):181. doi: 10.1186/s12883-016-0705-1.
• Zettl UK, Bauer-Steinhusen U, Glaser T, Czekalla J, Hechenbichler K, Limmroth V, Hecker M. Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary. Adv Ther. 2016 May;33(5):834-47. doi: 10.1007/s12325-016-0325-6. Epub 2016 Apr 18.
• Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V; Study Group. Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study. BMC Neurol. 2013 Sep 6;13:117. doi: 10.1186/1471-2377-13-117.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 13, 2009
• First Submitted That Met QC Criteria: May 13, 2009
• First Posted (Estimate): May 14, 2009

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Interferon beta-1b
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon-beta; Interferon beta-1b
• Other Study ID Numbers: 14543; BF0801DE (Other Identifier: Company internal)