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: January 20, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of early treatment termination [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Rate of study dropout [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Predictive value of BL parameters, WCQ, HADS, RODQ [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • WCQ (Ways of Coping Questionnaire) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • RODQ (Risk of Dropout Questionnaire) [ Time Frame: Monthly over 6 months; every other month thereafter ] [ Designated as safety issue: No ]
  • EDSS (Expanded Disability Status Scale) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 1723
Study Start Date: June 2008
Study Completion Date: November 2013
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
Genders Eligible for Study:   Both
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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00787657     History of Changes
Other Study ID Numbers: 13852, 311941, BF0703
Study First Received: November 6, 2008
Last Updated: January 20, 2014
Health Authority: Belgium: Ethics Committee
Canada: Ethics Review Committee
France: Institutional Ethical Committee
Israel: Ethics Commission
Italy: Ethics Committee
New Zealand: Institutional Review Board
Portugal: Health Ethic Committee
Singapore: Domain Specific Review Boards
Slovakia: State Institute for Drug Control
South Korea: Institutional Review Board
Taiwan: Institutional Review Board
United Kingdom: Research Ethics Committee
Colombia: Ethics Committee
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Sweden: Ethics Committee
Venezuela: Ethic Commitees & Instituto Nacional de Higiene
Norway: Ethics Committee
Slovenia: National Medical Ethics Committee of the Republic of Slovenia
Jordan: Ethical Committee
Lebanon: Institutional Review Board

Keywords provided by Bayer:
Clinically Isolated Syndrome (CIS)

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 July 28, 2014