check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

18016

ClinicalTrials.gov Identifier:

NCT02486640

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of potential predictors of adherence by investigating a representative cohort of Multiple Sclerosis (MS) patients in Germany treated with Betaferon

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A
  • -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
  • -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

Trial summary

Enrollment Goal
162
Trial Dates
September 2015 - January 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Wermsdorf, 04779, Germany
Withdrawn
Wuppertal, 42283, Germany
Withdrawn
Leipzig, 04275, Germany
Withdrawn
Hagen, 58095, Germany
Withdrawn
Bamberg, 96502, Germany
Withdrawn
Böblingen, 71034, Germany
Withdrawn
Stuttgart, 70174, Germany
Withdrawn
Lappersdorf, 93138, Germany
Withdrawn
Aschaffenburg, 63739, Germany
Withdrawn
Halle, 06120, Germany
Withdrawn
Westerstede, 26655, Germany
Withdrawn
Eschwege, 37269, Germany
Withdrawn
Bonn, 53105, Germany
Withdrawn
Bayreuth, 95445, Germany
Withdrawn
Altenholz-Stift, 24161, Germany
Withdrawn
Unterhaching, 82008, Germany
Withdrawn
Halle, 06112, Germany
Withdrawn
Heidenheim, 89518, Germany
Withdrawn
Baiersbronn - Schönmünzach, 72270, Germany
Withdrawn
Dresden, 01067, Germany
Withdrawn
Delbrück, 33129, Germany
Withdrawn
Emden, 26721, Germany
Withdrawn
Essen, 45257, Germany
Withdrawn
Rostock, 18055, Germany
Withdrawn
Berlin, 13347, Germany
Withdrawn
Stuttgart, 70182, Germany
Withdrawn
Sprockhövel, 45549, Germany
Withdrawn
Achim, 28832, Germany
Withdrawn
Stuttgart, 70178, Germany
Withdrawn
Berlin, 10713, Germany
Withdrawn
Nürnberg, 90491, Germany
Withdrawn
Jena, 07740, Germany
Withdrawn
Hamburg, 22179, Germany
Withdrawn
Teupitz, 15755, Germany
Withdrawn
Bogen, 94327, Germany
Withdrawn
Barsinghausen, 30890, Germany
Withdrawn
Berlin, 13088, Germany
Withdrawn
Ladenburg, 68526, Germany
Withdrawn
Gelsenkirchen, 45894, Germany

Primary Outcome

  • 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
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Persistence of therapy (Yes or No)
    Persistence is defined as patients continuing (“persisting”) their medication (regardless of the frequency of intake)
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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).
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Adherence to Betaferon treatment is associated with number of relapses (Yes or No)
    date_rangeTime Frame:
    12 months, 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Adherence to Betaferon treatment is associated with EDSS change (Yes or No)
    EDSS (Expanded Disability Status Scale)
    date_rangeTime Frame:
    12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

BETAPREDICT - MS patients treated with BETAferon®: PREDICTors of treatment adherence
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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