PERFECT: A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SC Peginterferon beta-1a 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). |
Drug: SC Peginterferon beta-1a
All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]).
Other Names:
|
| SC interferon beta-1a 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). |
Drug: SC interferon beta-1a
All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]).
Other Names:
|
| SC interferon beta-1b 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). |
Drug: SC interferon beta-1b
All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants [Day 1]
ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus.
- Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants [Day 1]
Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Secondary Outcome Measures
- Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Duration of ISR (FLS) Reported by Participants, Nurses, and Physician [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Interference Score of ISR (FLS) With Participant's Daily Activities [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. Interference of ISR (FLS) with participant's daily activities will be assessed by a visual analogue scale ranging from '0' (not at all) to '10' (extremely).
- Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
- Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy [Day 1]
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Ability to understand the purpose of the study and provide signed and dated informed consent
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Diagnosed relapsing-remitting multiple sclerosis
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Currently receiving a SC interferon beta treatment (label conform)
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Stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).
Key Exclusion Criteria:
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Contraindications according to the Fachinformation (German equivalent to Summary of Product Characteristics [SmPC])
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Treatment with Glatiramer acetate and intramuscular (IM) interferon beta-1a
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Participation in a non-interventional or interventional clinical study of Biogen
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Göttingen | Germany | 37073 |
Sponsors and Collaborators
- Biogen
- AMS Advanced Medical Services GmbH
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GER-PEG-16-10988