check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
17101
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY86-5046 (Betaseron), Non Interventional Studies
Trial purpose
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
151Trial Dates
June 2014 - June 2016Phase
Phase 4Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany |
Primary Outcome
- Adherence measure to Betaferon therapy based on the real BETACONNECT injectionsAdherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.date_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnairedate_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnairedate_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)date_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)date_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)date_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)date_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Local skin reactions recorded by Health Care Provider (HCP) evaluationdate_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT devicedate_rangeTime Frame:up to 24 weeksenhanced_encryptionNoSafety Issue:
- Number of Treatment-emergent Adverse Events (TEAE)date_rangeTime Frame:up to 24 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A