Brimonidine Tartrate for the Treatment of Injection Related Erythema

Relapsing-Remitting Multiple Sclerosis (RRMS) Clinical Trial

— BRITE  

Official title:

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02568111
• Other study ID #: NLD-PEG-14-10784
• Secondary ID: 2015-002159-89
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 1, 2015
• Last updated: February 12, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Biogen
• Contact: Biogen
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Erythema
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis (RRMS)

Intervention

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
• brimonidine tartrate
Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.
• Vehicle Gel
Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Before and after 6 hours of gel application	No
Secondary	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 participants' satisfaction therapy outcomes.	Before and after 6 hours of gel application	No
Secondary	Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA		Before and after 6 hours of gel application	No
Secondary	Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale	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).	Before and after 6 hours of gel application	No