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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01235455
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : November 1, 2012
Information provided by:

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) and depression questionnaire CES-D.

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

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Study Type : Observational
Actual Enrollment : 10 participants
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
Study Start Date : August 2007
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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 with RRMS or SPMS attending an hospital outpatient MS clinic

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

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 identifier (NCT number): NCT01235455

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Many Locations, Portugal
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Medical Director, Bayer Portugal SA Identifier: NCT01235455    
Other Study ID Numbers: 14235
BF0710PT ( Other Identifier: Company internal )
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by Bayer:
Multiple Sclerosis
Interferon beta-1b
Coping styles
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic