Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated with Sub-cutaneous Administration of Peginterferon beta-1a - BRITE

Biogen MA0 个研究点目标入组 32 人开始时间: 2015年8月25日最近更新: 2021年10月8日

适应症

试验速览

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•- RRMS patients naive to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician.
•- Patient and or legal representative is willing and able to understand the purpose and risks of the study and provide signed and dated informed consent.
•- Patient age 18 years or older.
•- Patient willing and able to complete PSA and PAA questionnaires with minimal assistance.
•- Development of injection site erythema with a score of 2 or higher on the PSA or CEA scale (occurring after first or second full dose of PLEGRIDY).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 32
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject’s ability to comply with the protocol.
•- Patients with history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
•- Known allergy to any interferon or any component of PLEGRIDY (peginterferon beta-1a).
•- Patients with hypersensitivity to Brimonidine topical gel.
•- Patients with other skin disorders.
•- History of previous treatment with Brimonidine tartrate (either eye drops or Mirvaso).
•- History of drug or alcohol abuse (as defined by the Investigator) within 6 months prior to Day 1.
•- Active bacterial or viral infection.
•- Female subjects who are pregnant or currently breastfeeding.
•- Inability to comply with study requirements.

发起方

Biogen MA