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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

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

October 14, 2010
November 14, 2012
April 2004
June 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01233245 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program
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 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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)

  • Relapsing Remitting MS (RRMS)
  • Secondary Progressive MS (SPMS)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
250 µg, sub-cutaneously, on alternate days
Group 1
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN β-1b in multiple sclerosis--results of the βPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1077
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Iran, Islamic Republic of,   Israel,   Italy,   Jordan,   Korea, Republic of,   Lebanon,   Netherlands,   Portugal,   Saudi Arabia,   Spain,   Taiwan,   Turkey
 
NCT01233245
14192, BF0704
No
Global Medical Affairs, Bayer Schering Pharma AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP