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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— PERFECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347370
• Other study ID #: GER-PEG-16-10988
• Status: Completed
• Start date: November 27, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Injection Site Reaction
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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]).
• 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]).
• 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.

Locations

Country	Name	City	State
Germany	Research Site	Göttingen

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	AMS Advanced Medical Services GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants	ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus.	Day 1
Primary	Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants	Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.	Day 1
Secondary	Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse	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.	Day 1
Secondary	Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician	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.	Day 1
Secondary	Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician	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.	Day 1
Secondary	Duration of ISR (FLS) Reported by Participants, Nurses, and Physician	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.	Day 1
Secondary	Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians	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.	Day 1
Secondary	Interference Score of ISR (FLS) With Participant's Daily Activities	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).	Day 1
Secondary	Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians	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.	Day 1
Secondary	Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS	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.	Day 1
Secondary	Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy	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.	Day 1
Secondary	Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy	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.	Day 1