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Trial record 1 of 1 for:    NCT01233245
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BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

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ClinicalTrials.gov Identifier: NCT01233245
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : November 15, 2012
Sponsor:
Information provided by:
Bayer

Study Description
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Brief Summary:
This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

Condition or disease Intervention/treatment
Relapsing Remitting MS (RRMS) Secondary Progressive MS (SPMS) Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Design
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Study Type : Observational
Actual Enrollment : 1077 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program
Study Start Date : April 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
250 µg, sub-cutaneously, on alternate days


Outcome Measures
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Primary Outcome Measures :
  1. Identification of reasons why patients are switched from other disease modifying drugs to Betaferon due to perceived lack of efficacy, adverse events, poor compliance, and others. [ Time Frame: After 2 years ]
  2. Assessment of factors predictive of non-adherence to disease modifying drugs such as demographic data, course of disease, drug history, patients characteristics, history of poor compliance to prior therapy or others. [ Time Frame: After 2 years ]

Secondary Outcome Measures :
  1. Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence. [ Time Frame: After 2 years ]
  2. Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS. [ Time Frame: After 2 years ]
  3. Assessment of coping processes by applying the Ways of Coping Questionnaire. [ Time Frame: After 2 years ]
  4. Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category. [ Time Frame: After 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, who were recruited at neurologic practices or specialized neurological centers, were eligible for selection if they had relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
Criteria

Inclusion Criteria:

  • Relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
  • Previous treatment with disease modifying drugs
  • Adjustment of disease modifying treatment necessary at the discretion of the investigator
  • Switch to Betaferon at least 1 month but not longer than 3 months prior to inclusion

Exclusion Criteria:

  • Patients not fulfilling the indications in the local prescribing information
  • Refusal to sign inform consent
Contacts and Locations
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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): NCT01233245


Locations
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Czech Republic
Many Locations, Czech Republic
France
Many Locations, France
Germany
Many Locations, Germany
Iran, Islamic Republic of
Many Locations, Iran, Islamic Republic of
Israel
Many Locations, Israel
Italy
Many Locations, Italy
Jordan
Many Locations, Jordan
Korea, Republic of
Many Locations, Korea, Republic of
Lebanon
Many Locations, Lebanon
Netherlands
Many Locations, Netherlands
Portugal
Many Locations, Portugal
Saudi Arabia
Many Locations, Saudi Arabia
Spain
Many Locations, Spain
Taiwan
Many Locations, Taiwan
Turkey
Many Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications of Results:

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Responsible Party: Global Medical Affairs, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT01233245    
Other Study ID Numbers: 14192
BF0704 ( Other Identifier: Company Internal )
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012
Keywords provided by Bayer:
Multiple Sclerosis
Adherence
Interferon beta-1b
Coping Styles
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic