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

NCT02486640 | Completed

• 2 other identifiers: 18016BF1502
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

RRMS, CIS

Outcome Measures

Primary Outcomes (3)

• 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))\*100

  12 months

• Persistence of therapy (Yes or No)

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

  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).

  12 months

Secondary Outcomes (5)

• Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire

  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)

  Up to 24 months

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

  12 months, 24 months

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

  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)

  Up to 24 months

Study Arms (1)

Betaferon

Drug: Interferon beta-1b (Betaferon, BAY86-5046); Device: Betaconnect Autoinjector

Interventions

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

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

Betaferon

Betaconnect Autoinjector DEVICE

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

Betaferon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) who are treated with Betaferon or will be treated with Betaferon according to the attending physician's decision and for whom the patient and the physician have agreed to use the BETACONNECT device

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Wermsdorf, Saxony, 04779, Germany

Location

Related Publications (1)

• Kohler W, Bayer-Gersmann K, Neusser T, Schurks M, Ziemssen T. Predictors of Adherence Among Patients With Multiple Sclerosis Using the BETACONNECT(R) Autoinjector: A Prospective Observational Cohort Study. Front Neurol. 2021 Feb 24;12:643126. doi: 10.3389/fneur.2021.643126. eCollection 2021.

  PMID: 33716945 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Multiple Sclerosis; Carcinoma in Situ

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 1, 2015
• Study Start: September 8, 2015
• Primary Completion: October 31, 2019
• Study Completion: January 16, 2020
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

DE (1)