Trial Condition(s):
Multiple Sclerosis
Evaluation of potential predictors of adherence by investigating a representative cohort of Multiple Sclerosis (MS) patients in Germany treated with Betaferon (BETAPREDICT)
Bayer Identifier:
18016
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon
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
Trial Summary
Enrollment Goal
162
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Wermsdorf, Germany, 04779 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
BETAPREDICT - MS patients treated with BETAferon®: PREDICTors of treatment adherence
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Compliance to therapy (%)Compliance (%) = ((expected # of treatment days during observation period - missed # of treatment days during observation period)/(expected # of treatment days during observation period))*100Timeframe: 12 months
- Persistence of therapy (Yes or No)Persistence is defined as patients continuing (“persisting”) their medication (regardless of the frequency of intake)Timeframe: 12 months
- Overall adherence to therapy (Yes or No)Patients will be defined as being adherent to therapy if they fulfill the following criteria: a. They have been at least 80% compliant, i.e. injected ≥80% of the expected Betaferon dosages and b. They have not dropped out of the study prior to the time of evaluation (i.e. they did not stop Betaferon treatment for any reason including switching to another medication prior to the time of evaluation).Timeframe: 12 months
Secondary Outcome
- Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaireTimeframe: Up to 24 months
- 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)Timeframe: Up to 24 months
- Adherence to Betaferon treatment is associated with number of relapses (Yes or No)Timeframe: 12 months, 24 months
- Adherence to Betaferon treatment is associated with EDSS change (Yes or No)EDSS (Expanded Disability Status Scale)Timeframe: 12 months, 24 months
- Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No)Timeframe: Up to 24 months
Additional Information
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