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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 August 2023 |
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Main ID: |
NCT02486640 |
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Date of registration:
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15/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
BETAPREDICT |
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Scientific title:
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BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence |
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Date of first enrolment:
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September 8, 2015 |
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Target sample size:
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162 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02486640 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged = 18 years with the diagnosis of relapsing remitting multiple sclerosis
or a clinically isolated syndrome
- Patients on treatment with Betaferon or the decision to treat patients with Betaferon
has been made by the attending physician
- Patients using or willing to use the BETACONNECT autoinjector for Betaferon
application
- Written informed consent
Exclusion Criteria:
- Patients receiving any other disease modifying drug
- Contraindications of Betaferon described in the Summary of Product Characteristics
- Patients participating in any other clinical or non-interventional study, evaluating
MS therapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Device: Betaconnect Autoinjector
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Drug: Interferon beta-1b (Betaferon, BAY86-5046)
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Primary Outcome(s)
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Persistence of therapy (Yes or No)
[Time Frame: 12 months]
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Compliance to therapy (%)
[Time Frame: 12 months]
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Overall adherence to therapy (Yes or No)
[Time Frame: 12 months]
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Secondary Outcome(s)
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Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No)
[Time Frame: Up to 24 months]
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Adherence to Betaferon treatment is associated with EDSS change (Yes or No)
[Time Frame: 12 months, 24 months]
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Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire
[Time Frame: Up to 24 months]
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Adherence to Betaferon treatment is associated with: depression, health related quality of life, coping mechanisms, self-management mechanisms, social support, fatigue, and cognition. (Yes or No)
[Time Frame: Up to 24 months]
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Adherence to Betaferon treatment is associated with number of relapses (Yes or No)
[Time Frame: 12 months, 24 months]
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Secondary ID(s)
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18016
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BF1502
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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