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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Betaferon Prospective Study on Adherence, Coping and Nursing Support
Secondary ID [1] 0 0
311941
Secondary ID [2] 0 0
13852
Universal Trial Number (UTN)
Trial acronym
BEACON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Remitting Multiple Sclerosis (RRMS) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients adhering to treatment
Timepoint [1] 0 0
6, 12, 18 and 24 months
Secondary outcome [1] 0 0
Rate of early treatment termination
Timepoint [1] 0 0
6, 12, 18 and 24 months
Secondary outcome [2] 0 0
Rate of study dropout
Timepoint [2] 0 0
6, 12, 18 and 24 months
Secondary outcome [3] 0 0
Predictive value of BL parameters, WCQ, HADS, RODQ
Timepoint [3] 0 0
12 and 24 months
Secondary outcome [4] 0 0
WCQ (Ways of Coping Questionnaire)
Timepoint [4] 0 0
6, 12, 18 and 24 months
Secondary outcome [5] 0 0
HADS (Hospital Anxiety and Depression Scale)
Timepoint [5] 0 0
6, 12, 18 and 24 months
Secondary outcome [6] 0 0
RODQ (Risk of Dropout Questionnaire)
Timepoint [6] 0 0
Monthly over 6 months; every other month thereafter
Secondary outcome [7] 0 0
EDSS (Expanded Disability Status Scale)
Timepoint [7] 0 0
6, 12, 18 and 24 months
Secondary outcome [8] 0 0
Relapse rate
Timepoint [8] 0 0
6, 12, 18 and 24 months

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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contra-indications as indicated in Betaferon summary of Products Characteristics
(SmPC)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
1723
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Many Locations
Country [2] 0 0
Bahrain
State/province [2] 0 0
Many Locations
Country [3] 0 0
Belgium
State/province [3] 0 0
Many Locations
Country [4] 0 0
Bosnia and Herzegovina
State/province [4] 0 0
Many Locations
Country [5] 0 0
Canada
State/province [5] 0 0
Many Locations
Country [6] 0 0
China
State/province [6] 0 0
Many Locations
Country [7] 0 0
Colombia
State/province [7] 0 0
Many Locations
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Many Locations
Country [9] 0 0
Egypt
State/province [9] 0 0
Many Locations
Country [10] 0 0
Estonia
State/province [10] 0 0
Many Locations
Country [11] 0 0
France
State/province [11] 0 0
Many Locations
Country [12] 0 0
Germany
State/province [12] 0 0
Many Locations
Country [13] 0 0
Iran, Islamic Republic of
State/province [13] 0 0
Many Locations
Country [14] 0 0
Israel
State/province [14] 0 0
Many Locations
Country [15] 0 0
Italy
State/province [15] 0 0
Many Locations
Country [16] 0 0
Jordan
State/province [16] 0 0
Many Locations
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Many Locations
Country [18] 0 0
Kuwait
State/province [18] 0 0
Many Locations
Country [19] 0 0
Lebanon
State/province [19] 0 0
Many Locations
Country [20] 0 0
Libyan Arab Jamahiriya
State/province [20] 0 0
Many Locations
Country [21] 0 0
Mexico
State/province [21] 0 0
Many Locations
Country [22] 0 0
Netherlands
State/province [22] 0 0
Many Locations
Country [23] 0 0
New Zealand
State/province [23] 0 0
Many Locations
Country [24] 0 0
Norway
State/province [24] 0 0
Many Locations
Country [25] 0 0
Pakistan
State/province [25] 0 0
Many Locations
Country [26] 0 0
Portugal
State/province [26] 0 0
Many Locations
Country [27] 0 0
Saudi Arabia
State/province [27] 0 0
Many Locations
Country [28] 0 0
Singapore
State/province [28] 0 0
Many Locations
Country [29] 0 0
Slovakia
State/province [29] 0 0
Many Locations
Country [30] 0 0
Slovenia
State/province [30] 0 0
Many Locations
Country [31] 0 0
Sweden
State/province [31] 0 0
Many Locations
Country [32] 0 0
Syrian Arab Republic
State/province [32] 0 0
Many Locations
Country [33] 0 0
Taiwan
State/province [33] 0 0
Many Locations
Country [34] 0 0
United Arab Emirates
State/province [34] 0 0
Many Locations
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Many Locations
Country [36] 0 0
Venezuela
State/province [36] 0 0
Many Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00787657
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries