Relapsing-Remitting Multiple SclerosisPhase 4VITALITYNCT03091569
Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy
A Phase 4 study testing Vitamin K Cream in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Vitamin K Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2017to 27 Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)
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.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Vitamin K Cream, Placebo Cream
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K CreamOther
Also called Filloskin K1
To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.
Placebo CreamOther
To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K | Active comparator | Not described Receives: Other: Vitamin K Cream |
| Control | Placebo comparator | Not described Receives: Other: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 4, week 6, and week 8
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)
Measured: Week 4, week 6, and week 8
Secondary outcomes (3)
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)
Measured: Week 4, week 6, and week 8
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.
Measured: Week 4, week 6, and week 8
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
Measured: Week 4, week 6, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start10 Mar 2017
- Primary completion27 Jan 2018
- Study completion27 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091569
- Sponsor's protocol ID
- ITA-PEG-15-10859
- Acronym
- VITALITY
- Status last verified
- Apr 2018
- First submitted
- 21 Mar 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)
- ClinicalTrials.gov ID
- NCT03091569
- Acronym / sponsor ID
- VITALITY / ITA-PEG-15-10859
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 27 Jan 2018 (actual)
- Study completion
- 27 Jan 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K | Active comparator | Other: Vitamin K Cream |
| Control | Placebo comparator | Other: Placebo Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K CreamAlso: Filloskin K1To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema. | Other | Vitamin K |
| Placebo CreamTo be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema. | Other | Control |
Primary outcome
Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application
Time frame: Week 4, week 6, and week 8
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
Time frame: Week 4, week 6, and week 8
Erythema (redness) at the site of injection rated by the participant on a scale of 0 (clear) to 4 (severe)
3 secondary outcomes
Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application
Time frame: Week 4, week 6, and week 8
Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application
Time frame: Week 4, week 6, and week 8
Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application
Time frame: Week 4, week 6, and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin K Cream in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application (time frame: Week 4, week 6, and week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.