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Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy (VITALITY)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Vitamin K Cream

Placebo Cream

About this trial

This is an interventional supportive care trial for Relapsing-Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Relapsing-Remitting Multiple Sclerosis (RRMS) participants for which Plegridy is deemed necessary by the neurologist. Participants switching from other Disease Modifying Treatments (DMTs) will be eligible provided that Plegridy is administered at an injection site different from the previous one.

Key Exclusion Criteria:

Participants with other skin disorders
Pregnancy or current breast-feeding
Depression and other psychiatric disorders
Unwillingness or inability to comply with the requirements of the protocol.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin K

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application

Erythema (redness) evaluated at the site of injection by the clinician on a scale of 0 (clear) to 4 (severe)

Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application

Erythema (redness) at the site of injection rated by the participant on a scale of 0 (clear) to 4 (severe)

Secondary Outcome Measures

Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application

Severity of local pain and burning assessed by the participant on a scale of 0 (no discomfort) to 10 (maximum discomfort imaginable)

Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application

Adapted MSTQC self-administered questionnaire evaluates the sum of scores for the "injection systems satisfaction" section questions 1-9 and the "side effects" section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. Lower total scores indicate better outcomes.

Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application

Measured by the physician using a ruler before and 24 hours after the topical application of cream

Full Information

NCT ID

NCT03091569

First Posted

March 21, 2017

Last Updated

April 4, 2018

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT03091569

Brief Title

Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy

Acronym

VITALITY

Official Title

Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

March 10, 2017 (Actual)

Primary Completion Date

January 27, 2018 (Actual)

Study Completion Date

January 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of the study is to investigate whether topical Vitamin K application reduces the grade of erythema in comparison with a vehicle cream (placebo) through physicians' assessment and participant self-assessment. The secondary objectives of this study are to evaluate in this study population: effects of Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing the erythema diameter; and the evaluation of participants' satisfaction related to the injection treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing-Remitting Multiple Sclerosis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin K

Arm Type

Active Comparator

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Vitamin K Cream

Other Intervention Name(s)

Filloskin K1

Intervention Description

To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.

Intervention Type

Other

Intervention Name(s)

Placebo Cream

Intervention Description

To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.

Primary Outcome Measure Information:

Title

Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application

Description

Erythema (redness) evaluated at the site of injection by the clinician on a scale of 0 (clear) to 4 (severe)

Time Frame

Week 4, week 6, and week 8

Title

Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application

Description

Erythema (redness) at the site of injection rated by the participant on a scale of 0 (clear) to 4 (severe)

Time Frame

Week 4, week 6, and week 8

Secondary Outcome Measure Information:

Title

Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application

Description

Severity of local pain and burning assessed by the participant on a scale of 0 (no discomfort) to 10 (maximum discomfort imaginable)

Time Frame

Week 4, week 6, and week 8

Title

Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application

Description

Time Frame

Week 4, week 6, and week 8

Title

Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application

Description

Measured by the physician using a ruler before and 24 hours after the topical application of cream

Time Frame

Week 4, week 6, and week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Relapsing-Remitting Multiple Sclerosis (RRMS) participants for which Plegridy is deemed necessary by the neurologist. Participants switching from other Disease Modifying Treatments (DMTs) will be eligible provided that Plegridy is administered at an injection site different from the previous one. Key Exclusion Criteria: Participants with other skin disorders Pregnancy or current breast-feeding Depression and other psychiatric disorders Unwillingness or inability to comply with the requirements of the protocol. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

12. IPD Sharing Statement

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Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy

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