check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
18016
ClinicalTrials.gov Identifier:
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
AllAge
18 - N/ATrial summary
Enrollment Goal
162Trial Dates
September 2015 - January 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Wuppertal, 42283, Germany | |
Withdrawn | Leipzig, 04275, Germany | |
Withdrawn | Hagen, 58095, Germany | |
Withdrawn | Bamberg, 96502, Germany | |
Withdrawn | Böblingen, 71034, Germany | |
Withdrawn | Stuttgart, 70174, Germany | |
Withdrawn | Lappersdorf, 93138, Germany | |
Withdrawn | Aschaffenburg, 63739, Germany | |
Withdrawn | Halle, 06120, Germany | |
Withdrawn | Westerstede, 26655, Germany | |
Withdrawn | Eschwege, 37269, Germany | |
Withdrawn | Bonn, 53105, Germany | |
Withdrawn | Bayreuth, 95445, Germany | |
Withdrawn | Altenholz-Stift, 24161, Germany | |
Withdrawn | Unterhaching, 82008, Germany | |
Withdrawn | Halle, 06112, Germany | |
Withdrawn | Heidenheim, 89518, Germany | |
Withdrawn | Baiersbronn - Schönmünzach, 72270, Germany | |
Withdrawn | Dresden, 01067, Germany | |
Withdrawn | Delbrück, 33129, Germany | |
Withdrawn | Emden, 26721, Germany | |
Withdrawn | Essen, 45257, Germany | |
Withdrawn | Rostock, 18055, Germany | |
Withdrawn | Berlin, 13347, Germany | |
Withdrawn | Stuttgart, 70182, Germany | |
Withdrawn | Sprockhövel, 45549, Germany | |
Withdrawn | Achim, 28832, Germany | |
Withdrawn | Stuttgart, 70178, Germany | |
Withdrawn | Berlin, 10713, Germany | |
Withdrawn | Nürnberg, 90491, Germany | |
Withdrawn | Jena, 07740, Germany | |
Withdrawn | Hamburg, 22179, Germany | |
Withdrawn | Teupitz, 15755, Germany | |
Withdrawn | Bogen, 94327, Germany | |
Withdrawn | Barsinghausen, 30890, Germany | |
Withdrawn | Berlin, 13088, Germany | |
Withdrawn | Ladenburg, 68526, Germany | |
Withdrawn | Gelsenkirchen, 45894, Germany |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))*100date_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnairedate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionYesSafety Issue:
- Adherence to Betaferon treatment is associated with number of relapses (Yes or No)date_rangeTime Frame:12 months, 24 monthsenhanced_encryptionYesSafety Issue:
- Adherence to Betaferon treatment is associated with EDSS change (Yes or No)EDSS (Expanded Disability Status Scale)date_rangeTime Frame:12 months, 24 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A