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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01233245
First received: October 14, 2010
Last updated: November 14, 2012
Last verified: November 2012
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
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: | 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
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:
|
Multiple Sclerosis 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 June 18, 2013