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

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ClinicalTrials.gov Identifier: NCT00787657
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : October 16, 2015
Information provided by (Responsible Party):

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

Study Type : Observational
Actual Enrollment : 1723 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Betaferon Prospective Study on Adherence, Coping and Nursing Support
Study Start Date : June 2008
Primary Completion Date : September 2013
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

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)

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 ClinicalTrials.gov identifier (NCT number): NCT00787657

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

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 )
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 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
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic