Subcutaneous Interferon beta therapy in multiple sclerosis patients and characterization of injection site reactions and flu-like symptoms under daily practice setting (PERFECT)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Post-authorization safety study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  INTERFERON BETA-1A

  INTERFERON BETA-1B
• Medical condition to be studied:
  Relapsing-remitting multiple sclerosis

Population studied

• Short description of the study population:
  Adult relapsing-remitting multiple sclerosis (RRMS) patients receiving a Subcutaneous (SC) Interferon beta therapy.; Inclusion criteria; • Ability to understand the purpose of the study and provide signed and dated informed consent; • At least 18 years at time of 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); Exclusion criteria; • Contraindications according to the “Fachinformation” (German equivalent to Summary of Product Characteristics [SmPC]); • Therapy with Glatiramer acetate or intramuscular (IM) Interferon beta-1a; • Participation in a non-interventional or interventional clinical study of Biogen
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Relapsing-remitting multiple sclerosis patients
• Estimated number of subjects:
  626

Study design details

• Main study objective:
  The purpose of this study 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.
• Outcomes:
  • Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants• Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants, Participants with at Least 1 ISR (FLS), Types of ISR, Duration and Time of Occurrence of ISR Reported by Participants, Nurses, and PhysicianInterference Score of ISR With Participant’s Daily ActivitiesParticipants Taking Actions to Relieve the ISR (FLS) and Resulting in Relief of ISR/FLSParticipants With Reducing/Increasing Frequency and Intensity of ISR/FLS Compared to Previous Therapy
• Data analysis plan:
  All documented data are analyzed by descriptive statistics, that is, no formal statistical hypothesis will be formulated and no statistical tests will be carried out. All analyses will be performed based on the data set of patients who were eligible for participation according to inclusion criteria and completed the questionnaire. If a patient omits a specific question, he will be set to missing in all analyses referring to this question. No data imputation will be performed.

Documents

Study results

GER-PEG-16-10988_CSR Synopsis_16-Jun-2020