E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Erythema at injection site after Plegridy injection for the treatment of Multiple Sclerose. |
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E.1.1.1 | Medical condition in easily understood language |
Development of redness after the injection of Plegridy for the treatment of Multiple Sclerose (MS). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the IRE mitigation effect of a single administration of Brimonidine tartrate in comparison with a vehicle gel (placebo). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |