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Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors (POR-BetaPlus)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01235455
First received: November 4, 2010
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  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) and depression questionnaire CES-D.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Portuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus Program

Resource links provided by NLM:

U.S. FDA Resources

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: 10
Study Start Date: August 2007
Study Completion Date: May 2011
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 with RRMS or SPMS attending an hospital outpatient MS clinic

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235455

Locations
Portugal
Many Locations, Portugal
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Portugal SA
ClinicalTrials.gov Identifier: NCT01235455     History of Changes
Other Study ID Numbers: 14235, BF0710PT
Study First Received: November 4, 2010
Last Updated: October 30, 2012
Health Authority: Portugal: National Pharmacy and Medicines Institute

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

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
 Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 19, 2013