BAY86-5046 (Betaseron), Non Interventional Studies

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02121444
• Date of registration: 22/04/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: BAY86-5046 (Betaseron), Non Interventional Studies BETAEVAL
• Scientific title: BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
• Date of first enrolment: June 23, 2014
• Target sample size: 151
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02121444
• Study type: Observational
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically
isolated syndrome.

- Patients must be on treatment with Betaferon or the decision to treat patients with
Betaferon has been made by the attending physician.

- Patient and attending physicians must have agreed on the usage of the BETACONNECT
auto-injector device

- Written informed consent must be obtained.

Exclusion Criteria:

- Patients receiving any other disease modifying drug.

- Contraindications of Betaferon described in the Summary of Product Characteristics.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Interferon beta-1b (Betaferon, BAY 86-5046)

Device: BETACONNECT auto-injector.

Primary Outcome(s)

Adherence measure to Betaferon therapy based on the real BETACONNECT injections [Time Frame: up to 24 weeks]

Secondary Outcome(s)

Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT) [Time Frame: up to 24 weeks]

Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC) [Time Frame: up to 24 weeks]

Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire [Time Frame: up to 24 weeks]

Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D) [Time Frame: up to 24 weeks]

Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire [Time Frame: up to 24 weeks]

Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device [Time Frame: up to 24 weeks]

Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS) [Time Frame: up to 24 weeks]

Number of Treatment-emergent Adverse Events (TEAE) [Time Frame: up to 24 weeks]

Local skin reactions recorded by Health Care Provider (HCP) evaluation [Time Frame: up to 24 weeks]

Secondary ID(s)

BF1414DE

17101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors