Multiple Sclerosis, Relapsing-RemittingPERFECTNCT03347370
A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- SC Peginterferon beta-1a, SC interferon beta-1a and SC interferon beta-1b
- How many people
- 626 participants
- Where
- 1 siteGermany
- Study dates
- 27 Nov 2017to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with RRMS, who are currently stable on a SC interferon beta treatment for at least three months and maximum four years (switch between SC interferon beta treatments possible) will be enrolled in the study.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- SC Peginterferon beta-1a, SC interferon beta-1a, SC interferon beta-1b
- Keywords
- subcutaneous interferon beta therapy multiple sclerosis (MS), injection site reactions (ISR), flu-like symptoms (FLS), non-interventional study (NIS), SC Peginterferon beta-1a, SC interferon beta-1a, SC interferon beta-1b, Plegridy®, Betaferon®, Extavia®, Rebif®
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC Peginterferon beta-1aDrug
Also called Plegridy
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-1aDrug
Also called Rebif
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-1bDrug
Also called Betaferon, Extavia
All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: SC Peginterferon beta-1a | |
| 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). Receives: Drug: SC interferon beta-1a | |
| 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). Receives: Drug: SC interferon beta-1b |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (10)
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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).
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start27 Nov 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AMS Advanced Medical Services GmbH
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347370
- Sponsor's protocol ID
- GER-PEG-16-10988
- Acronym
- PERFECT
- Status last verified
- Sep 2019
- First submitted
- 16 Nov 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03347370
- Acronym / sponsor ID
- PERFECT / GER-PEG-16-10988
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- subcutaneous interferon beta therapy multiple sclerosis (MS), injection site reactions (ISR), flu-like symptoms (FLS), non-interventional study (NIS), SC Peginterferon beta-1a, SC interferon beta-1a, SC interferon beta-1b, Plegridy®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- AMS Advanced Medical Services GmbH
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SC Peginterferon beta-1a | – | Drug: SC Peginterferon beta-1aParticipants 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). |
| SC interferon beta-1a | – | Drug: SC interferon beta-1aParticipants 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). |
| SC interferon beta-1b | – | Drug: SC interferon beta-1bParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with RRMS, who are currently stable on a SC interferon beta treatment for at least three months and maximum four years (switch between SC interferon beta treatments possible) will be enrolled in the study.
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC Peginterferon beta-1aAlso: PlegridyAll participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]). | Drug | SC Peginterferon beta-1a |
| SC interferon beta-1aAlso: RebifAll participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]). | Drug | SC interferon beta-1a |
| SC interferon beta-1bAlso: Betaferon, ExtaviaAll participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product. | Drug | SC interferon beta-1b |
Primary outcome
Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants
Time frame: 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
Time frame: Day 1
Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
10 secondary outcomes
Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse
Time frame: Day 1
Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician
Time frame: Day 1
Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician
Time frame: Day 1
Duration of ISR (FLS) Reported by Participants, Nurses, and Physician
Time frame: Day 1
Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians
Time frame: Day 1
Interference Score of ISR (FLS) With Participant's Daily Activities
Time frame: Day 1
Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians
Time frame: Day 1
Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS
Time frame: Day 1
Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy
Time frame: Day 1
Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.