A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis (PERFECT)

Biogen

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: SC interferon beta-1b; Drug: SC interferon beta-1a; Drug: SC Peginterferon beta-1a

Study type: Observational

Funder types: Industry

Identifiers

NCT03347370

GER-PEG-16-10988

Details and patient eligibility

About

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 by the relapsing-remitting multiple sclerosis (RRMS) participants.

Enrollment: 626 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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

Trial design

626 participants in 3 patient groups

SC Peginterferon beta-1a

Description:

Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).

Treatment:

Drug: SC Peginterferon beta-1a

SC interferon beta-1a

Description:

Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).

Treatment:

Drug: SC interferon beta-1a

SC interferon beta-1b

Description:

Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).

Treatment:

Drug: SC interferon beta-1b