check_circleStudy Completed

Relapsing Remitting Multiple Sclerosis (RRMS)

Bayer Identifier:

13852

ClinicalTrials.gov Identifier:

NCT00787657

EudraCT Number:

Not Available

EU CT Number:

Not Available
Observational Study to analyse the impact of nurse support and disease related factors on long- term adherence to Betaferon treatment

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.

Key Participants Requirements

Sex

Both

Age

12 - N/A
  • - 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.


  • - Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)

Trial summary

Enrollment Goal
1723
Trial Dates
June 2008 - October 2014
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Czech Republic
Completed
Many Locations, Israel
Completed
Many Locations, Portugal
Completed
Many Locations, Slovakia
Completed
Many Locations, New Zealand
Completed
Many Locations, Saudi Arabia
Terminated
Many Locations, Iran
Completed
Many Locations, Kuwait
Completed
Many Locations, Lebanon
Completed
Many Locations, United Arab Emirates
Terminated
Many Locations, Germany
Completed
Many Locations, United Kingdom
Completed
Many Locations, France
Completed
Many Locations, Italy
Terminated
Many Locations, Canada
Completed
Many Locations, Belgium
Completed
Many Locations, Netherlands
Completed
Many Locations, Mexico
Terminated
Many Locations, Sweden
Completed
Many Locations, Norway
Completed
Many Locations, Colombia
Completed
Many Locations, China
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Taiwan
Completed
Many Locations, Venezuela
Terminated
Many Locations, Singapore
Completed
Many Locations, Slovenia
Terminated
Many Locations, Pakistan
Completed
Many Locations, Egypt
Completed
Many Locations, Jordan
Completed
Many Locations, Bahrain
Completed
Many Locations, Syria
Completed
Many Locations, Bosnia And Herzegovina
Completed
Many Locations, Libya
Completed
Many Locations, Argentina
Completed
Many Locations, Estonia

Primary Outcome

  • Proportion of patients adhering to treatment
    date_rangeTime Frame:
    6, 12, 18 and 24 months
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    Safety Issue:
    No

Secondary Outcome

  • Rate of early treatment termination
    date_rangeTime Frame:
    6, 12, 18 and 24 months
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    Safety Issue:
    No
  • Rate of study dropout
    date_rangeTime Frame:
    6, 12, 18 and 24 months
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    Safety Issue:
    No
  • Predictive value of BL parameters, WCQ, HADS, RODQ
    date_rangeTime Frame:
    12 and 24 months
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    Safety Issue:
    No
  • WCQ (Ways of Coping Questionnaire)
    date_rangeTime Frame:
    6, 12, 18 and 24 months
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    Safety Issue:
    No
  • HADS (Hospital Anxiety and Depression Scale)
    date_rangeTime Frame:
    6, 12, 18 and 24 months
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    Safety Issue:
    No
  • RODQ (Risk of Dropout Questionnaire)
    date_rangeTime Frame:
    Monthly over 6 months; every other month thereafter
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    Safety Issue:
    No
  • EDSS (Expanded Disability Status Scale)
    date_rangeTime Frame:
    6, 12, 18 and 24 months
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    Safety Issue:
    No
  • Relapse rate
    date_rangeTime Frame:
    6, 12, 18 and 24 months
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    Safety Issue:
    No

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
N/A

Additional Information

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