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Completed

NCT Number: NCT02486640

Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon

This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Carcinoma Carcinoma in Situ Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wermsdorf, Saxony, 04779, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Interferon beta-1b (Betaferon, BAY86-5046)

Drug

Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.

Betaconnect Autoinjector

Device

Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.

Primary outcomes

  1. Compliance to therapy (%)

    Time frame: 12 months

    Compliance (%) = ((expected # of treatment days during observation period - missed # of treatment days during observation period)/(expected # of treatment days during observation period))*100

  2. Persistence of therapy (Yes or No)

    Time frame: 12 months

    Persistence is defined as patients continuing ("persisting") their medication (regardless of the frequency of intake)

  3. Overall adherence to therapy (Yes or No)

    Time frame: 12 months

    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).

Secondary outcomes

  1. Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire

    Time frame: Up to 24 months

  2. 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

  3. Adherence to Betaferon treatment is associated with number of relapses (Yes or No)

    Time frame: 12 months, 24 months

  4. Adherence to Betaferon treatment is associated with EDSS change (Yes or No)

    Time frame: 12 months, 24 months

    EDSS (Expanded Disability Status Scale)

  5. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence

Acronym: BETAPREDICT

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jul 1, 2015
Registry last updated
Jul 24, 2023

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.

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