PERFECT
What it found
We found no results in the registry or in papers.
This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Peginterferon beta-1a
Interferon alpha/beta receptor agonist
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Interferon beta-1b
Interferon alpha/beta receptor agonist
What it measured
Main measures
Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants
Day 1
PainSafetyPercentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants
Day 1
FatigueSafety
Other measures (10)
Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse
Day 1
FatiguePainSafetyPercentage of Participants with at Least one ISR (FLS) as Reported by the Physician
Day 1
FatiguePainSafetyPercentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician
Day 1
FatiguePainSafetyDuration of ISR (FLS) Reported by Participants, Nurses, and Physician
Day 1
FatiguePainSafetyUsual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians
Day 1
FatiguePainSafetyInterference Score of ISR (FLS) With Participant's Daily Activities
Day 1
Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians
Day 1
FatiguePainSafetyPercentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS
Day 1
FatiguePainSafetyPercentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy
Day 1
FatiguePainSafetyPercentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy
Day 1
FatiguePainSafety
Who could take part
Relapsing MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Nov 2017
Main results due
Jul 2019
Finished
Jul 2019
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