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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00902135
First received: May 13, 2009
Last updated: June 17, 2014
Last verified: June 2014

May 13, 2009
June 17, 2014
May 2009
December 2013   (final data collection date for primary outcome measure)
Drop out rate over 2 years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00902135 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Relapsing-Remitting Multiple Sclerosis
  • 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 1
    Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
  • Group 2
    Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
  • Group 3
    Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
735
July 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00902135
14543, BF0801DE
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP