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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02247310
• Date of registration: 19/09/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon
• Scientific title: BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
• Date of first enrolment: October 20, 2014
• Target sample size: 498
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02247310
• Study type: Observational
• Phase: N/A

Countries of recruitment

Austria, Belgium, Bosnia and Herzegovina, Croatia, Czech Republic, Czechia, France, Greece, Hungary, Italy, Netherlands, Spain, Switzerland

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing Remitting

Intervention(s)

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

Device: BETACONNECT

Primary Outcome(s)

Adherence to therapy at the final visit. [Time Frame: Up to 24 weeks]

Secondary Outcome(s)

Injection site pain and prophylactic analgesic use [Time Frame: At baseline,4 weeks,12 weeks and 24 weeks]

Cognition [Time Frame: At baseline,12 weeks and 24 weeks]

Fatigue [Time Frame: At baseline,12 weeks and 24 weeks]

Anxiety [Time Frame: At baseline,12 weeks and 24 weeks]

Health related quality of life [Time Frame: At baseline,12 weeks and 24 weeks]

Satisfaction with and evaluation of the BETACONNECT auto-injector [Time Frame: At baseline,4 weeks,12 weeks and 24 weeks]

Depression [Time Frame: At baseline,12 weeks and 24 weeks]

Injection-related specifics [Time Frame: At 4 weeks,12 weeks and 24 weeks]

Local skin reactions [Time Frame: At baseline,4 weeks,12 weeks and 24 weeks]

Secondary ID(s)

BF1401

17591

Source(s) of Monetary Support

Please refer to primary and secondary sponsors