Erythema at injection site after Plegridy injection for the treatment of Multiple Sclerose.
Conditions
Interventions
Trade Name: Mirvaso
Pharmaceutical Form: Gel
INN or Proposed INN: BRIMONIDINE
CAS Number: 59803-98-4
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 3.3-
Pha
Sponsors
Biogen MA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the IRE mitigation effect of a single administration of Brimonidine tartrate in comparison with a vehicle gel (placebo).;Primary end point(s): A change in either CEA or 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 patient, respectively, 6 hours after gel application, compared to the same measure before gel application.;Timepoint(s) of evaluation of this end point: 6 hours after treatment;Secondary Objective: 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 patients’ satisfaction with the overall appearance of their skin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - A 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 patients’ satisfaction therapy outcomes. CEA and PSA assessments will be performed before gel application, and then 6 hours after gel application at the physician’s office. - A composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA; - Subject’s self-assessment of satisfaction with the overall appearance of their skin by using a Patient’s Assessment of Appearance (PAA) grading scale.;Timepoint(s) of evaluation of this end point: 6 hours after treatment | — |
Countries
Netherlands
Contacts
Public ContactChawwa Visser
Venn Life Sciences
Outcome results
None listed