Back to resultsBrimonidine Tartrate for the Treatment of Injection Related Erythema (BRITE)
Primary Purpose
Relapsing-Remitting Multiple Sclerosis (RRMS)
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
peginterferon beta-1a
brimonidine tartrate
Vehicle Gel
Sponsored by
About this trial
This is an interventional supportive care trial for Relapsing-Remitting Multiple Sclerosis (RRMS) focused on measuring erythema, PLEGRIDY, injection site reaction (ISR), MS, RRMS
Eligibility Criteria
Key Inclusion Criteria:
- 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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
brimonidine tartrate
Vehicle Gel
Arm Description
Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection
Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02568111
Brief Title
Brimonidine Tartrate for the Treatment of Injection Related Erythema
Acronym
BRITE
Official Title
Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis (RRMS)
Keywords
erythema, PLEGRIDY, injection site reaction (ISR), MS, RRMS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brimonidine tartrate
Arm Type
Experimental
Arm Description
Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection
Intervention Type
Drug
Intervention Name(s)
peginterferon beta-1a
Other Intervention Name(s)
PEGylated Interferon Beta-1a, PEG IFN β-1a, Plegridy, BIIB017
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
brimonidine tartrate
Other Intervention Name(s)
Mirvaso
Intervention Description
Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Before and after 6 hours of gel application
Secondary Outcome Measure Information:
Title
Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively
Description
This composite endpoint is considered to be sensitive enough and directly correlated with participants' satisfaction therapy outcomes.
Time Frame
Before and after 6 hours of gel application
Title
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
Title
Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale
Description
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).
Time Frame
Before and after 6 hours of gel application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Brimonidine Tartrate for the Treatment of Injection Related Erythema
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