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Brimonidine Tartrate for the Treatment of Injection Related Erythema (BRITE)

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ClinicalTrials.gov Identifier: NCT02568111
Recruitment Status : Withdrawn
First Posted : October 5, 2015
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:

The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo).

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 participants' satisfaction with the overall appearance of their skin.


Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis (RRMS) Drug: peginterferon beta-1a Drug: brimonidine tartrate Drug: Vehicle Gel Phase 4

Detailed Description:
Participants naïve to treatment with subcutaneous (SC) interferons or oral Disease Modifying Therapy (DMT) who are about to start PLEGRIDY PEN therapy will be screened for participation in this Phase IV trial. Participants will remain on Plegridy therapy as prescribed by their physician. Plegridy will not be provided to participants by Biogen as a part of this study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)
Study Start Date : February 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: brimonidine tartrate
Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection
 Drug: peginterferon beta-1a
SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29
Other Names:
  • PEGylated Interferon Beta-1a
  • PEG IFN β-1a
  • Plegridy
  • BIIB017

Drug: brimonidine tartrate
Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.
Other Name: Mirvaso
Placebo Comparator: Vehicle Gel
Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection
 Drug: peginterferon beta-1a
SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29
Other Names:
  • PEGylated Interferon Beta-1a
  • PEG IFN β-1a
  • Plegridy
  • BIIB017

Drug: Vehicle Gel
Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.


Outcome Measures
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Primary Outcome Measures :
  1. Change in either Clinician's Erythema Assessment (CEA) or Patient Erythema Self-Assessment (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 participant [ Time Frame: Before and after 6 hours of gel application ]
    Investigator will evaluate participant's erythema (redness) at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema. Participants rate erythema at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema.


Secondary Outcome Measures :
  1. Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively [ Time Frame: Before and after 6 hours of gel application ]
    This composite endpoint is considered to be sensitive enough and directly correlated with participants' satisfaction therapy outcomes.

  2. Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA [ Time Frame: Before and after 6 hours of gel application ]
  3. Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale [ Time Frame: Before and after 6 hours of gel application ]
    PAA satisfaction score will describe how satisfied the participants are with the overall appearance of skin on a scale of 0 (very satisfied) to 4 (very dissatisfied).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • RRMS patients naïve to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician.
  • Patient willing and able to complete PSA and PAA questionnaires with minimal assistance.

Key Exclusion Criteria:

  • Known allergy to any interferon or any component of peginterferon beta-1a.
  • Patients with hypersensitivity to Brimonidine topical gel.
  • Patients with other skin disorders.
  • History of previous treatment with Brimonidine tartrate.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568111


Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02568111    
Other Study ID Numbers: NLD-PEG-14-10784
2015-002159-89 ( EudraCT Number )
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Keywords provided by Biogen:
erythema
PLEGRIDY
injection site reaction (ISR)
MS
RRMS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Erythema
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Skin Manifestations
Interferons
Interferon-beta
Interferon beta-1a
 Brimonidine Tartrate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic