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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 5, 2015
Last Update Posted Date April 25, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02568111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
  • 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.
  • 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 ]
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brimonidine Tartrate for the Treatment of Injection Related Erythema
Official Title  ICMJE Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Relapsing-Remitting Multiple Sclerosis (RRMS)
Intervention  ICMJE
  • 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
  • Drug: Vehicle Gel
    Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.
Study Arms  ICMJE
  • Experimental: brimonidine tartrate
    Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection
    Interventions:
    • Drug: peginterferon beta-1a
    • Drug: brimonidine tartrate
  • Placebo Comparator: Vehicle Gel
    Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection
    Interventions:
    • Drug: peginterferon beta-1a
    • Drug: Vehicle Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 21, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2015)
32
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568111
Other Study ID Numbers  ICMJE NLD-PEG-14-10784
2015-002159-89 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP