Multiple Sclerosis, Relapsing-Remitting Clinical Trial
— PERFECTOfficial title:
Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting
Verified date | September 2019 |
Source | Biogen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Research Site | Göttingen |
Lead Sponsor | Collaborator |
---|---|
Biogen | AMS Advanced Medical Services GmbH |
Germany,
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 |
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