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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902135
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : July 17, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment
Relapsing-Remitting Multiple Sclerosis Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type : Observational
Actual Enrollment : 702 participants
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)
Study Start Date : May 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
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)

Primary Outcome Measures :
  1. Drop out rate over 2 years [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Disability status [ Time Frame: After 3, 6, 12 and 24 months ]
  2. Grade of depressiveness [ Time Frame: After 3, 6, 12 and 24 months ]
  3. Grade of fatigue [ Time Frame: After 3, 6, 12 and 24 months ]
  4. Quality of life [ Time Frame: After 3, 6, 12 and 24 months ]
  5. Cognitive status [ Time Frame: After 12 and 24 months ]
  6. Injection regularity [ Time Frame: After 3, 6, 12 and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00902135

Many Locations, Germany
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT00902135     History of Changes
Other Study ID Numbers: 14543
BF0801DE ( Other Identifier: Company internal )
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015

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

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