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BAY86-5046 (Betaseron), Non Interventional Studies (BETAEVAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02121444
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date April 22, 2014
First Posted Date April 23, 2014
Last Update Posted Date October 18, 2017
Actual Study Start Date June 23, 2014
Actual Primary Completion Date March 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2014)
Adherence measure to Betaferon therapy based on the real BETACONNECT injections [ Time Frame: up to 24 weeks ]
Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02121444 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 22, 2014)
  • Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire [ Time Frame: up to 24 weeks ]
  • Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire [ Time Frame: up to 24 weeks ]
  • Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS) [ Time Frame: up to 24 weeks ]
  • Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: up to 24 weeks ]
  • Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC) [ Time Frame: up to 24 weeks ]
  • Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT) [ Time Frame: up to 24 weeks ]
  • Local skin reactions recorded by Health Care Provider (HCP) evaluation [ Time Frame: up to 24 weeks ]
  • Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device [ Time Frame: up to 24 weeks ]
  • Number of Treatment-emergent Adverse Events (TEAE) [ Time Frame: up to 24 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BAY86-5046 (Betaseron), Non Interventional Studies
Official Title BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
Brief Summary This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Multiple Sclerosis
Intervention
  • Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
  • Device: BETACONNECT auto-injector.
Study Groups/Cohorts Cohort 1
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector
Interventions:
  • Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
  • Device: BETACONNECT auto-injector.
Publications * Kleiter I, Lang M, Jeske J, Norenberg C, Stollfuß B, Schürks M. Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study. BMC Neurol. 2017 Sep 6;17(1):174. doi: 10.1186/s12883-017-0953-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 8, 2016)
151
Original Estimated Enrollment
 (submitted: April 22, 2014)
150
Actual Study Completion Date June 1, 2016
Actual Primary Completion Date March 9, 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
  • Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02121444
Other Study ID Numbers 17101
BF1414DE ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2017