- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02486640
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon (BETAPREDICT)
July 20, 2023 updated by: Bayer
BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence
This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
162
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sachsen
-
Wermsdorf, Sachsen, Germany, 04779
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Betaferon
|
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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)
|
12 months
|
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).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire
Time Frame: Up to 24 months
|
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)
Time Frame: Up to 24 months
|
Up to 24 months
|
|
Adherence to Betaferon treatment is associated with number of relapses (Yes or No)
Time Frame: 12 months, 24 months
|
12 months, 24 months
|
|
Adherence to Betaferon treatment is associated with EDSS change (Yes or No)
Time Frame: 12 months, 24 months
|
EDSS (Expanded Disability Status Scale)
|
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)
Time Frame: Up to 24 months
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bayer Study Director, Bayer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2015
Primary Completion (Actual)
October 31, 2019
Study Completion (Actual)
January 16, 2020
Study Registration Dates
First Submitted
June 15, 2015
First Submitted That Met QC Criteria
June 29, 2015
First Posted (Estimated)
July 1, 2015
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 20, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon-beta
- Interferon beta-1b
Other Study ID Numbers
- 18016
- BF1502 (Registry Identifier: NIS Trial Alias)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
Clinical Trials on Interferon beta-1b (Betaferon, BAY86-5046)
-
BayerCompleted
-
BayerWithdrawnMultiple SclerosisSweden, Denmark
-
BayerCompletedMultiple Sclerosis, Relapsing-RemittingUnited States
-
BayerCompletedHeart Diseases | CardiomyopathiesItaly, Spain, Germany, Poland, United Kingdom, Sweden, France
-
BayerCompletedMultiple SclerosisRussian Federation
-
BayerCompleted
-
BayerCompletedMultiple Sclerosis, Relapsing-RemittingBelgium, Israel, Sweden, United States, France, Switzerland, Ireland, Canada, Australia, Brazil, Austria, Poland, Germany, Hungary, Netherlands, Russian Federation, Spain, Argentina, Slovenia, Greece, Finland, Denmark, Ukraine, Italy, L... and more
-
BayerCompleted
-
BayerWithdrawnMultiple Sclerosis, Relapsing-RemittingKorea, Republic of
-
BayerCompleted