Brimonidine Tartrate for the Treatment of Injection Related Erythema
- Conditions
- Relapsing-Remitting Multiple Sclerosis (RRMS)
- Interventions
- Registration Number
- NCT02568111
- Lead Sponsor
- Biogen
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Gel peginterferon beta-1a Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection brimonidine tartrate brimonidine tartrate Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection Vehicle Gel Vehicle Gel Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection brimonidine tartrate peginterferon beta-1a Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively Before and after 6 hours of gel application 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 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 Before and after 6 hours of gel application 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).