Skip to main content
OpenTrials
Completed

NCT Number: NCT02121444

BAY86-5046 (Betaseron), Non Interventional Studies

This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

BETACONNECT auto-injector.

Device

Primary outcomes

  1. Adherence measure to Betaferon therapy based on the real BETACONNECT injections

    Time frame: up to 24 weeks

    Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.

Secondary outcomes

  1. Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire

    Time frame: up to 24 weeks

  2. 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

  3. Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)

    Time frame: up to 24 weeks

  4. Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: up to 24 weeks

  5. Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)

    Time frame: up to 24 weeks

  6. Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)

    Time frame: up to 24 weeks

  7. Local skin reactions recorded by Health Care Provider (HCP) evaluation

    Time frame: up to 24 weeks

  8. 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

  9. Number of Treatment-emergent Adverse Events (TEAE)

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®

Acronym: BETAEVAL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.