BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02247310
• Collaborator: (none)
• Enrollment: 498
• Locations: 11
• Actual Duration (Months): 24.6
• Patients Per Site: 45.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Relapsing Remitting	Drug: Interferon beta-1b (Betaferon®, BAY 86-5046); Device: BETACONNECT

Study Design

• Study Type: Observational
• Actual Enrollment: 498 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
• Actual Study Start Date: Oct 20, 2014
• Actual Primary Completion Date: Jul 19, 2016
• Actual Study Completion Date: Nov 8, 2016

Arms and Interventions

Arm	Intervention/Treatment
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); Patients will be treated with Betaferon; Device: BETACONNECT; Auto-injector device to support the injection of Betaferon

Outcome Measures

Primary Outcome Measures

1. Adherence to therapy at the final visit. [Up to 24 weeks]

Secondary Outcome Measures

1. Satisfaction with and evaluation of the BETACONNECT auto-injector [At baseline,4 weeks,12 weeks and 24 weeks]

   Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire

2. Injection site pain and prophylactic analgesic use [At baseline,4 weeks,12 weeks and 24 weeks]

   Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire

3. Health related quality of life [At baseline,12 weeks and 24 weeks]

   Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.

4. Anxiety [At baseline,12 weeks and 24 weeks]

   Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).

5. Depression [At baseline,12 weeks and 24 weeks]

   Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).

6. Fatigue [At baseline,12 weeks and 24 weeks]

   Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).

7. Cognition [At baseline,12 weeks and 24 weeks]

   Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).

8. Local skin reactions [At baseline,4 weeks,12 weeks and 24 weeks]

   Local skin reactions will be recorded by HCP evaluation (local inspection).

9. Injection-related specifics [At 4 weeks,12 weeks and 24 weeks]

   Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

Exclusion Criteria:

• Patients receiving any other disease modifying drug.

• Contraindications of Betaferon described in the Summary of Product Characteristics.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many locations		Austria
2		Many locations		Belgium
3		Many Locations		Bosnia and Herzegovina
4		Many locations		Croatia
5		Many Locations		Czechia
6		Many locations		France
7		Many locations		Greece
8		Many locations		Hungary
9		Many locations		Italy
10		Many locations		Spain
11		Many locations		Switzerland

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02247310
• Other Study ID Numbers: 17591; BF1401
• First Posted: Sep 25, 2014
• Last Update Posted: Nov 7, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Interferons; Interferon-beta; Interferon beta-1b

Study Results

No Results Posted as of Nov 7, 2017