Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Biogen
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
brimonidine tartrate
Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection
干预措施: peginterferon beta-1a (Drug)
brimonidine tartrate
Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection
干预措施: brimonidine tartrate (Drug)
Vehicle Gel
Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection
干预措施: peginterferon beta-1a (Drug)
Vehicle Gel
Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)
- 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)