Clinical trial NCT03347370: A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
Official title: Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: subcutaneous interferon beta therapy multiple sclerosis (MS)
injection site reactions (ISR)
flu-like symptoms (FLS)
non-interventional study (NIS)
SC Peginterferon beta-1a
SC interferon beta-1a
SC interferon beta-1b
Plegridy®
Betaferon®
Extavia®
Rebif®
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AMS Advanced Medical Services GmbH
First posted: 2017-11-20
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with RRMS, who are currently stable on a SC interferon beta treatment for at least three months and maximum four years (switch between SC interferon beta treatments possible) will be enrolled in the study.

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


Eligibility 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

Primary outcomes:
measure: Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants
timeFrame: Day 1
measure: Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse
timeFrame: Day 1
measure: Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician
timeFrame: Day 1
measure: Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician
timeFrame: Day 1
measure: Duration of ISR (FLS) Reported by Participants, Nurses, and Physician
timeFrame: Day 1
measure: Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians
timeFrame: Day 1
measure: Interference Score of ISR (FLS) With Participant's Daily Activities
timeFrame: Day 1
measure: Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians
timeFrame: Day 1
measure: Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS
timeFrame: Day 1
measure: Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy
timeFrame: Day 1
measure: Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy
timeFrame: Day 1
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: