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

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00902135
First received: May 13, 2009
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Relapsing-Remitting Multiple Sclerosis
 Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Drop out rate over 2 years [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability status [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Grade of depressiveness [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Grade of fatigue [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Cognitive status [ Time Frame: After 12 and 24 months ] [ Designated as safety issue: No ]
  • Injection regularity [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: May 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder
Group 2 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder
Group 3 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902135

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Germany
Recruiting
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Vital GmbH
ClinicalTrials.gov Identifier: NCT00902135     History of Changes
Other Study ID Numbers: 14543, BF0801DE
Study First Received: May 13, 2009
Last Updated: April 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Multiple Sclerosis
Interferon beta-1b

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 22, 2013