Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated with Sub-cutaneous Administration of Peginterferon beta-1a
- Conditions
- Erythema at injection site after Plegridy injection for the treatment of Multiple Sclerose.Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002159-89-NL
- Lead Sponsor
- Biogen MA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- 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).
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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;<br>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.<br>- A composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA;<br>- 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