Clinical trial NCT02486640: Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Official title: BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: RRMS, CIS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Compliance to therapy (%)
timeFrame: 12 months
measure: Persistence of therapy (Yes or No)
timeFrame: 12 months
measure: Overall adherence to therapy (Yes or No)
timeFrame: 12 months
Secondary outcomes:
measure: Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire
timeFrame: Up to 24 months
measure: 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)
timeFrame: Up to 24 months
measure: Adherence to Betaferon treatment is associated with number of relapses (Yes or No)
timeFrame: 12 months, 24 months
measure: Adherence to Betaferon treatment is associated with EDSS change (Yes or No)
timeFrame: 12 months, 24 months
measure: Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Wermsdorf
country: Germany
state: Sachsen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kohler W, Bayer-Gersmann K, Neusser T, Schurks M, Ziemssen T. Predictors of Adherence Among Patients With Multiple Sclerosis Using the BETACONNECT(R) Autoinjector: A Prospective Observational Cohort Study. Front Neurol. 2021 Feb 24;12:643126. doi: 10.3389/fneur.2021.643126. eCollection 2021.