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

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ClinicalTrials.gov Identifier: NCT02486640
Recruitment Status : Active, not recruiting
First Posted : July 1, 2015
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon beta-1b (Betaferon, BAY86-5046) Device: Betaconnect Autoinjector

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Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence
Actual Study Start Date : September 8, 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Betaferon Drug: Interferon beta-1b (Betaferon, BAY86-5046)
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector.

Device: Betaconnect Autoinjector
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector.




Primary Outcome Measures :
  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 Outcome Measures :
  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 EQ5-D quality of life questionnaire (Yes or No) [ Time Frame: Up to 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
  • Patients must be using the BETACONNECTTM auto-injector for Betaferon application.
  • 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.
  • Patients participating in any other clinical or noninterventional study, evaluating MS therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486640


Locations
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Germany
Multiple Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02486640     History of Changes
Other Study ID Numbers: 18016
BF1502 ( Registry Identifier: NIS Trial Alias )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

Keywords provided by Bayer:
RRMS, CIS

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic