Relapsing-Remitting Multiple Sclerosis (RRMS)Phase 4BRITENCT02568111
Brimonidine Tartrate for the Treatment of Injection Related Erythema
A Phase 4 study testing peginterferon beta-1a and brimonidine tartrate in people with Relapsing-Remitting Multiple Sclerosis (RRMS), run by Biogen.
Trial summary
The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis (RRMS)
- What is being tested?
- peginterferon beta-1a and brimonidine tartrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2016
- Phase
- Phase 4
- 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
Who may be able to join
- RRMS patients naïve to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician.
- Patient willing and able to complete PSA and PAA questionnaires with minimal assistance.
Who cannot join
- Known allergy to any interferon or any component of peginterferon beta-1a.
- Patients with hypersensitivity to Brimonidine topical gel.
- Patients with other skin disorders.
- History of previous treatment with Brimonidine tartrate.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
About this study
Official title: Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)
The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo).
The secondary study objectives are to evaluate the IRE mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent definition scale, in accordance with the primary endpoint of the original brimonidine pivotal trials and participants' satisfaction with the overall appearance of their skin.
Read the detailed description
Participants naïve to treatment with subcutaneous (SC) interferons or oral Disease Modifying Therapy (DMT) who are about to start PLEGRIDY PEN therapy will be screened for participation in this Phase IV trial. Participants will remain on Plegridy therapy as prescribed by their physician. Plegridy will not be provided to participants by Biogen as a part of this study.
- Being tested
- peginterferon beta-1a, brimonidine tartrate, Vehicle Gel
- Keywords
- erythema, PLEGRIDY, injection site reaction (ISR), MS, RRMS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Erythema, Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon beta-1aDrug
Also called PEGylated Interferon Beta-1a, PEG IFN β-1a, Plegridy, BIIB017
SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29
brimonidine tartrateDrug
Also called Mirvaso
Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.
Vehicle GelDrug
Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.
| Study group | Role | What they receive |
|---|---|---|
| brimonidine tartrate | Experimental | Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection Receives: Drug: peginterferon beta-1a; Drug: brimonidine tartrate |
| Vehicle Gel | Placebo comparator | Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection Receives: Drug: peginterferon beta-1a; Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in either Clinician's Erythema Assessment (CEA) or Patient Erythema Self-Assessment (PSA) scale measured as at least 1-grade improvement on CEA and/or at least 1-grade improvement on PSA scale assessed by the physician and participant
Investigator will evaluate participant's erythema (redness) at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema. Participants rate erythema at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema.
Measured: Before and after 6 hours of gel application
Secondary outcomes (3)
Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively
This composite endpoint is considered to be sensitive enough and directly correlated with participants' satisfaction therapy outcomes.
Measured: Before and after 6 hours of gel application
Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA
Measured: Before and after 6 hours of gel application
Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale
PAA satisfaction score will describe how satisfied the participants are with the overall appearance of skin on a scale of 0 (very satisfied) to 4 (very dissatisfied).
Measured: Before and after 6 hours of gel application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple Sclerosis (RRMS)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568111
- Sponsor's protocol ID
- NLD-PEG-14-10784
- Other IDs
- 2015-002159-89, 2015
- Acronym
- BRITE
- Status last verified
- Apr 2016
- First submitted
- 1 Oct 2015
- Last updated
- 25 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)
- ClinicalTrials.gov ID
- NCT02568111
- Acronym / sponsor ID
- BRITE / NLD-PEG-14-10784
- Keywords
- erythema, PLEGRIDY, injection site reaction (ISR), MS, RRMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- 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 primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo).
The secondary study objectives are to evaluate the IRE mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent definition scale, in accordance with the primary endpoint of the original brimonidine pivotal trials and participants' satisfaction with the overall appearance of their skin.
Detailed description
Participants naïve to treatment with subcutaneous (SC) interferons or oral Disease Modifying Therapy (DMT) who are about to start PLEGRIDY PEN therapy will be screened for participation in this Phase IV trial. Participants will remain on Plegridy therapy as prescribed by their physician. Plegridy will not be provided to participants by Biogen as a part of this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brimonidine tartrate | Experimental | Drug: peginterferon beta-1a, Drug: brimonidine tartrateParticipants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection |
| Vehicle Gel | Placebo comparator | Drug: peginterferon beta-1a, Drug: Vehicle GelParticipants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- RRMS patients naïve to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician.
- Patient willing and able to complete PSA and PAA questionnaires with minimal assistance.
Key exclusion criteria (5 listed)
- Known allergy to any interferon or any component of peginterferon beta-1a.
- Patients with hypersensitivity to Brimonidine topical gel.
- Patients with other skin disorders.
- History of previous treatment with Brimonidine tartrate.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| peginterferon beta-1aAlso: PEGylated Interferon Beta-1a, PEG IFN β-1a, Plegridy, BIIB017SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29 | Drug | Vehicle Gel, brimonidine tartrate |
| brimonidine tartrateAlso: MirvasoApplied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma. | Drug | brimonidine tartrate |
| Vehicle GelMatched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma. | Drug | Vehicle Gel |
Primary outcome
Change in either Clinician's Erythema Assessment (CEA) or Patient Erythema Self-Assessment (PSA) scale measured as at least 1-grade improvement on CEA and/or at least 1-grade improvement on PSA scale assessed by the physician and participant
Time frame: Before and after 6 hours of gel application
Investigator will evaluate participant's erythema (redness) at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema. Participants rate erythema at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema.
3 secondary outcomes
Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively
Time frame: Before and after 6 hours of gel application
Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA
Time frame: Before and after 6 hours of gel application
Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale
Time frame: Before and after 6 hours of gel application
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing peginterferon beta-1a and brimonidine tartrate in people with Relapsing-Remitting Multiple Sclerosis (RRMS), run by Biogen.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in either Clinician's Erythema Assessment (CEA) or Patient Erythema Self-Assessment (PSA) scale measured as at least 1-grade improvement on CEA and/or at least 1-grade improvement on PSA scale assessed by the physician and participant (time frame: Before and after 6 hours of gel application). 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 Apr 2016.