Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated with Sub-cutaneous Administration of Peginterferon beta-1a
- Conditions
- erythemaredness of the skin100013161000381610047043
- Registration Number
- NL-OMON42363
- Lead Sponsor
- Biogen MA Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
- 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).
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A change in either CEA or PSA scale measured as at least 1-grade improvement on<br /><br>CEA and/or at least 1-grade improvement on PSA scale assessed by the physician<br /><br>and patient, respectively, 6 hours after gel application, compared to the same<br /><br>measure before gel application.</p><br>
- Secondary Outcome Measures
Name Time Method <p>A composite change in both CEA and PSA scale measured as at least 1-grade<br /><br>improvement on CEA and 1-grade improvement on PSA respectively; This composite<br /><br>endpoint is considered to be sensitive enough and directly correlated with<br /><br>patients* satisfaction therapy outcomes. CEA and PSA assessments will be<br /><br>performed before gel application, and then 6 hours after gel application at the<br /><br>physician*s office.<br /><br><br /><br>A composite change in both CEA and PSA scale measured as at least 2-grade<br /><br>improvement on CEA and 2-grade improvement on PSA;<br /><br><br /><br>Subject*s self-assessment of satisfaction with the overall appearance of their<br /><br>skin by using a Patient*s Assessment of Appearance (PAA) grading scale.<br /><br><br /><br>At least 2-grade change on CEA scale recorded 6 hours after gel application at<br /><br>the site of erythema affected skin.</p><br>