Trial Condition(s):
Relapsing Remitting Multiple Sclerosis (RRMS)
Observational Study to analyse the impact of nurse support and disease related factors on long- term adherence to Betaferon treatment (BEACON)
Bayer Identifier:
13852
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Czech Republic | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Portugal | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovakia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, New Zealand | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Iran | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kuwait | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Lebanon | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Arab Emirates | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Germany | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Kingdom | Status Completed | Contact Us: E-mail: [email protected]ayerhealthcare.com Phone: Not Available |
Locations Investigative Site Many Locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Canada | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Belgium | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Mexico | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Sweden | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Norway | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, South Korea | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Taiwan, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Venezuela | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Singapore | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovenia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Pakistan | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Egypt | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Jordan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bahrain | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Syria | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bosnia and Herzegovina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Libya | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Estonia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Betaferon prospective study on Adherence, Coping and Nursing Support
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Proportion of patients adhering to treatmentTimeframe: 6, 12, 18 and 24 months
Secondary Outcome
- Rate of early treatment terminationTimeframe: 6, 12, 18 and 24 months
- Rate of study dropoutTimeframe: 6, 12, 18 and 24 months
- Predictive value of BL parameters, WCQ, HADS, RODQTimeframe: 12 and 24 months
- WCQ (Ways of Coping Questionnaire)Timeframe: 6, 12, 18 and 24 months
- HADS (Hospital Anxiety and Depression Scale)Timeframe: 6, 12, 18 and 24 months
- RODQ (Risk of Dropout Questionnaire)Timeframe: Monthly over 6 months; every other month thereafter
- EDSS (Expanded Disability Status Scale)Timeframe: 6, 12, 18 and 24 months
- Relapse rateTimeframe: 6, 12, 18 and 24 months
Additional Information
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