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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00787657
Registration number
NCT00787657
Ethics application status
Date submitted
6/11/2008
Date registered
7/11/2008
Date last updated
16/10/2015
Titles & IDs
Public title
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
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Scientific title
Betaferon Prospective Study on Adherence, Coping and Nursing Support
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Secondary ID [1]
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311941
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Secondary ID [2]
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13852
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Universal Trial Number (UTN)
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Trial acronym
BEACON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Remitting Multiple Sclerosis (RRMS)
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1b (Betaseron, BAY86-5046)
Arm 1 -
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of patients adhering to treatment
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Assessment method [1]
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Timepoint [1]
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6, 12, 18 and 24 months
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Secondary outcome [1]
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Rate of early treatment termination
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Assessment method [1]
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Timepoint [1]
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6, 12, 18 and 24 months
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Secondary outcome [2]
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Rate of study dropout
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Assessment method [2]
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Timepoint [2]
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6, 12, 18 and 24 months
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Secondary outcome [3]
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Predictive value of BL parameters, WCQ, HADS, RODQ
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Assessment method [3]
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Timepoint [3]
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12 and 24 months
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Secondary outcome [4]
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WCQ (Ways of Coping Questionnaire)
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Assessment method [4]
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Timepoint [4]
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6, 12, 18 and 24 months
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Secondary outcome [5]
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HADS (Hospital Anxiety and Depression Scale)
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Assessment method [5]
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Timepoint [5]
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6, 12, 18 and 24 months
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Secondary outcome [6]
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RODQ (Risk of Dropout Questionnaire)
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Assessment method [6]
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Timepoint [6]
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Monthly over 6 months; every other month thereafter
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Secondary outcome [7]
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EDSS (Expanded Disability Status Scale)
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Assessment method [7]
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Timepoint [7]
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6, 12, 18 and 24 months
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Secondary outcome [8]
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Relapse rate
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Assessment method [8]
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Timepoint [8]
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6, 12, 18 and 24 months
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Eligibility
Key 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.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2008
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
1723
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Argentina
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Bahrain
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Belgium
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Bosnia and Herzegovina
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Canada
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China
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Colombia
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Czech Republic
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Egypt
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Estonia
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France
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Germany
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Iran, Islamic Republic of
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Israel
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Italy
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Jordan
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Libyan Arab Jamahiriya
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Portugal
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Sweden
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Syrian Arab Republic
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Venezuela
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00787657
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Trial related presentations / publications
Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Address
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Bayer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00787657
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