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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01233245
First received: October 14, 2010
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assessment of coping processes by applying the Ways of Coping Questionnaire. [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1077
Study Start Date: April 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
250 µg, sub-cutaneously, on alternate days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233245

Locations
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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Global Medical Affairs, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT01233245     History of Changes
Other Study ID Numbers: 14192, BF0704
Study First Received: October 14, 2010
Last Updated: November 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Iran: Ministry of Health
Israel: Ministry of Health
Italy: The Italian Medicines Agency
South Korea: Korea Food and Drug Administration (KFDA)
Netherlands: Independent Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
Taiwan: Center for Drug Evaluation
Taiwan : Food and Drug Administration
Jordan: Jordan Food and Drug Administration

Keywords provided by Bayer:
Multiple Sclerosis
Adherence
Interferon beta-1b
Coping Styles

Additional relevant MeSH terms:
Sclerosis
Multiple 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
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 18, 2014