Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis (BREAK)
|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.|
|ClinicalTrials.gov Identifier: NCT01184833|
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : June 25, 2013
Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients.
Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures.
This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Interferon beta-1b (Betaseron, BAY86-5046)|
|Study Type :||Observational|
|Actual Enrollment :||852 participants|
|Official Title:||Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis|
|Study Start Date :||September 2008|
|Actual Study Completion Date :||August 2011|
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.
- Rate of discontinuation of Betaferon [ Time Frame: 24 months ]
- Number of missed doses of Betaferon [ Time Frame: 24 months ]
- Depression score as measured by CES-D questionnaire [ Time Frame: 24 months ]
- Neurological disability score as measured by EDSS scale [ Time Frame: 24 months ]
- Overall tolerability of treatment as measured by rate of adverse events [ Time Frame: 24 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01184833
|Many Locations, Poland|
|Study Director:||Bayer Study Director||Bayer|