Primary ObjectivesTo evaluate the IRE intensity/color mitigation effect of a single administration of Brimonidine tartrate in comparison with a vehicle gel (placebo).Secondary ObjectiveTo evaluate the IRE intensity/color mitigation effect of a…
ID
Source
Brief title
Condition
- Administration site reactions
- Autoimmune disorders
- Skin vascular abnormalities
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
At least 2-grade change on CEA scale recorded 6 hours after gel application at
the site of erythema affected skin.
Background summary
PLEGRIDY (peginterferon *-1a) is a disease modifying therapy indicated to treat
patients with relapsing forms of multiple sclerosis (RRMS). Pegylation of IFN
*-1a has allowed, among other advantages, a longer half-life leading to less
frequent dosing regimen compared to the original molecule which can translate
in a better treatment experience for MS patients. During the Phase III pivotal
PLEGRIDY trial in IFN treatment naïve patients, injection site erythema was the
most common adverse event reported by patients in the active treatment arm
(64%) over the course of 2 years. One possible Injection Site Reaction
mitigation strategy is topical vasoconstriction at the injection site. On this
basis, the vasoconstriction effect of Brimonidine tartrate might help alleviate
the injections related erythema associated with sub-cutaneous administration of
peginterferon beta-1a. A clinically meaningful reduction of the
Injection-Related Erythema (IRE) is hypothesized to improve the patient*s
treatment experience possibly leading to a positive impact on therapy
adherence.
Study objective
Primary Objectives
To evaluate the IRE intensity/color mitigation effect of a single
administration of Brimonidine tartrate in comparison with a vehicle gel
(placebo).
Secondary Objective
To evaluate the IRE intensity/color 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.
Study design
The BRITE study is a double blinded, self-controlled, cross-over Phase IV study
to assess topical application of Brimonidine tartrate gel on mitigation of
erythema severity in order to achieve an even better treatment experience with
PLEGRIDY in patients who develop mild to moderate injection site erythema
according to the Clinician*s Erythema Assessment (CEA) and the Patient
Self-Assessment (PSA). CEA and PSA are two 5-point scales specifically
developed for the Brimonidine pivotal trial that assess the erythema severity
on clinicians* and patients* judgment, respectively.
Intervention
Patients will be randomised after erythema has developed within 72 hours after
post full dose Plegridy injection. During this visit the gel will be applied
(either placebo or brimonidine tartrate) and the patients will complete the
questionnaires pre-application and 6 hours post application.
Study burden and risks
The patient will have a maximum of three study specific visits. During the
first visit Informed consent will be signed if the patient wants to participate
and if the patient is eligible per protocol criteria. Also medical history will
be collected and a dermatological exam will be performed. A maximum of 2 visits
will take place after inclusion. During these visits the gel will be applied
(placebo or brimonidine tartrate and vice versa) and the questionnaires will be
completed pre gel application and 6 hours post-application.
Binney Street 225
Cambridge MA 02142
US
Binney Street 225
Cambridge MA 02142
US
Listed location countries
Age
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).
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-002159-89-NL |
| ClinicalTrials.gov | NCT0256811 |
| CCMO | NL53602.100.15 |