Status:
COMPLETED
A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
Lead Sponsor:
Biogen
Collaborating Sponsors:
AMS Advanced Medical Services GmbH
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to investigate the safety of subcutaneous (SC) interferon beta therapies with regard to frequency of injection site reactions (ISR) and flu-like symptoms (FLS) as reported...
Eligibility Criteria
Inclusion
- Key
- Ability to understand the purpose of the study and provide signed and dated informed consent
- Diagnosed relapsing-remitting multiple sclerosis
- Currently receiving a SC interferon beta treatment (label conform)
- Stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).
- Key
Exclusion
- Contraindications according to the Fachinformation (German equivalent to Summary of Product Characteristics \[SmPC\])
- Treatment with Glatiramer acetate and intramuscular (IM) interferon beta-1a
- Participation in a non-interventional or interventional clinical study of Biogen
Key Trial Info
Start Date :
November 27 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT03347370
Start Date
November 27 2017
End Date
July 31 2019
Last Update
September 25 2019
Active Locations (1)
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1
Research Site
Göttingen, Germany, 37073