NCT02121444

Brief Summary

This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 23, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

April 22, 2014

Last Update Submit

October 16, 2017

Conditions

Multiple Sclerosis

Keywords

RRMSCIS

Outcome Measures

Primary Outcomes (1)

  • Adherence measure to Betaferon therapy based on the real BETACONNECT injections

    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.

    up to 24 weeks

Secondary Outcomes (9)

  • Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire

    up to 24 weeks

  • Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire

    up to 24 weeks

  • Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)

    up to 24 weeks

  • Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)

    up to 24 weeks

  • Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)

    up to 24 weeks

  • +4 more secondary outcomes

Study Arms (1)

Cohort 1

Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector

Drug: Interferon beta-1b (Betaferon, BAY 86-5046)Device: BETACONNECT auto-injector.

Interventions

Interferon beta-1b (Betaferon, BAY 86-5046)DRUG
Cohort 1
BETACONNECT auto-injector.DEVICE
Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients receiving any other disease modifying drug.
  • Contraindications of Betaferon described in the Summary of Product Characteristics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

Related Publications (1)

  • Kleiter I, Lang M, Jeske J, Norenberg C, Stollfuss B, Schurks M. Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT(R) autoinjector: a prospective observational cohort study. BMC Neurol. 2017 Sep 6;17(1):174. doi: 10.1186/s12883-017-0953-8.

    PMID: 28877664DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 23, 2014

Study Start

June 23, 2014

Primary Completion

March 9, 2016

Study Completion

June 1, 2016

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

DE(1)