NCT02247310

Brief Summary

Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias. To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
11 countries

11 active sites

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

September 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

October 20, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2016

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

September 19, 2014

Last Update Submit

November 5, 2017

Conditions

Multiple Sclerosis, Relapsing Remitting

Outcome Measures

Primary Outcomes (1)

  • Adherence to therapy at the final visit.

    Up to 24 weeks

Secondary Outcomes (9)

  • Satisfaction with and evaluation of the BETACONNECT auto-injector

    At baseline,4 weeks,12 weeks and 24 weeks

  • Injection site pain and prophylactic analgesic use

    At baseline,4 weeks,12 weeks and 24 weeks

  • Health related quality of life

    At baseline,12 weeks and 24 weeks

  • Anxiety

    At baseline,12 weeks and 24 weeks

  • Depression

    At baseline,12 weeks and 24 weeks

  • +4 more secondary outcomes

Study Arms (1)

Cohort 1

Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device.

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

Interventions

Interferon beta-1b (Betaferon®, BAY 86-5046)DRUG

Patients will be treated with Betaferon

Cohort 1
BETACONNECTDEVICE

Auto-injector device to support the injection of Betaferon

Cohort 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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. The study will be conducted in neurological centers and neurology departments specialized in the treatment of Multiple Sclerosis patients.

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 a patient 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 (11)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Belgium

Location

Unknown Facility

Many Locations, Bosnia and Herzegovina

Location

Unknown Facility

Many Locations, Croatia

Location

Unknown Facility

Many Locations, Czechia

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Greece

Location

Unknown Facility

Many Locations, Hungary

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Spain

Location

Unknown Facility

Many Locations, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating 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

September 19, 2014

First Posted

September 25, 2014

Study Start

October 20, 2014

Primary Completion

July 19, 2016

Study Completion

November 8, 2016

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

GR(1)CH(1)ES(1)HU(1)BE(1)BO(1)CZ(1)CR(1)AU(1)FR(1)IT(1)