Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment (BEACON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00787657
First received: November 6, 2008
Last updated: October 15, 2015
Last verified: October 2015
  Purpose
  • The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
  • The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Betaferon Prospective Study on Adherence, Coping and Nursing Support

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of patients adhering to treatment [ Time Frame: 6, 12, 18 and 24 months ]

Secondary Outcome Measures:
  • Rate of early treatment termination [ Time Frame: 6, 12, 18 and 24 months ]
  • Rate of study dropout [ Time Frame: 6, 12, 18 and 24 months ]
  • Predictive value of BL parameters, WCQ, HADS, RODQ [ Time Frame: 12 and 24 months ]
  • WCQ (Ways of Coping Questionnaire) [ Time Frame: 6, 12, 18 and 24 months ]
  • HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 6, 12, 18 and 24 months ]
  • RODQ (Risk of Dropout Questionnaire) [ Time Frame: Monthly over 6 months; every other month thereafter ]
  • EDSS (Expanded Disability Status Scale) [ Time Frame: 6, 12, 18 and 24 months ]
  • Relapse rate [ Time Frame: 6, 12, 18 and 24 months ]

Enrollment: 1723
Study Start Date: June 2008
Study Completion Date: October 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients after clinical events suggestive of MS according to SMPC) and patients with elapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis
Criteria

Inclusion Criteria:

  • Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.

Exclusion Criteria:

  • Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787657

  Show 36 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00787657     History of Changes
Other Study ID Numbers: 13852
311941 ( Other Identifier: company internal )
BF0703 ( Other Identifier: company internal )
Study First Received: November 6, 2008
Last Updated: October 15, 2015

Keywords provided by Bayer:
Clinically Isolated Syndrome (CIS)

Additional relevant MeSH terms:
Multiple 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
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 22, 2017