Multiple SclerosisEMPOWERNCT03316404
Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response
An observational study of Multiple Sclerosis and MS, run by DxTerity Diagnostics at 1 site in United States.
Trial summary
To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, MS
- How many people
- 1,168 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 25 Feb 2020
- Phase
- Observational
- 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
Study population: Participants diagnosed with Multiple Sclerosis (MS)
Who may be able to join
- Male and female patients age 18 or older
- Have a permanent address in the United States for the duration of the study
- Have an email address and access to the internet for the duration of the study
- Able to provide informed consent
- Self-reported diagnosis of MS
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.
Read the detailed description
Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system (CNS) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. It impairs control of bodily functions and leads to clinical disability as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically develops in young adults; primarily women in their early 30s. The etiology of MS is not fully understood, but it is noted that the prevalence of MS differs with geography and ethnicity.
Biomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. To establish a baseline and further characterize gene expression in MS, blood samples from individuals with MS will be collected. A rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. In the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of MS.
In order to analyze gene expression data from individuals diagnosed with MS, the study will collect blood samples and information from up to 1500 subjects for analysis.
- Conditions
- Multiple Sclerosis, MS
- Keywords
- Multiple Sclerosis, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cohort 1 of the study will collect blood samples from participants in various states of the disease. After qualification and informed consent, accepted participants will be sent a blood collection kit and will be asked to complete a study-related questionnaire. | |
| Cohort 2 | Cohort 2 may be conducted at selected clinical sites where MS treatment-naïve patients who are entering a new treatment paradigm will be sought. At the clinical site, patients will be qualified, consented, and a small amount (up to 1mL) of blood will be collected. Between approximately 1 week and 6 months of treatment on the new drug, the participant will be sent another blood collection kit for microsample collection and a brief questionnaire at home. A final sample will be collected between 3 and 6 months after the start of treatment. Within 6 months of initiating treatment, the site will be asked to provide information regarding the health and treatment status of the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS) to develop a blood test to characterize MS status by analyzing gene expression from blood samples.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start7 Nov 2017
- Primary completion24 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- DxTerity Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316404
- Sponsor's protocol ID
- DXT-MCD-AD02
- Acronym
- EMPOWER
- Status last verified
- Aug 2024
- First submitted
- 17 Oct 2017
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response
- ClinicalTrials.gov ID
- NCT03316404
- Acronym / sponsor ID
- EMPOWER / DXT-MCD-AD02
- Conditions
- Multiple Sclerosis, MS
- Keywords
- Multiple Sclerosis, MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- DxTerity DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 20 Oct 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.
To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.
Detailed description
Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system (CNS) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. It impairs control of bodily functions and leads to clinical disability as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically develops in young adults; primarily women in their early 30s. The etiology of MS is not fully understood, but it is noted that the prevalence of MS differs with geography and ethnicity.
Biomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. To establish a baseline and further characterize gene expression in MS, blood samples from individuals with MS will be collected. A rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. In the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of MS.
In order to analyze gene expression data from individuals diagnosed with MS, the study will collect blood samples and information from up to 1500 subjects for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Cohort 1 of the study will collect blood samples from participants in various states of the disease. After qualification and informed consent, accepted participants will be sent a blood collection kit and will be asked to complete a study-related questionnaire. |
| Cohort 2 | – | –Cohort 2 may be conducted at selected clinical sites where MS treatment-naïve patients who are entering a new treatment paradigm will be sought. At the clinical site, patients will be qualified, consented, and a small amount (up to 1mL) of blood will be collected. Between approximately 1 week and 6 months of treatment on the new drug, the participant will be sent another blood collection kit for microsample collection and a brief questionnaire at home. A final sample will be collected between 3 and 6 months after the start of treatment. Within 6 months of initiating treatment, the site will be asked to provide information regarding the health and treatment status of the participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with Multiple Sclerosis (MS)
Key inclusion criteria (5 listed)
- Male and female patients age 18 or older
- Have a permanent address in the United States for the duration of the study
- Have an email address and access to the internet for the duration of the study
- Able to provide informed consent
- Self-reported diagnosis of MS
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)
Time frame: 2 years
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS) to develop a blood test to characterize MS status by analyzing gene expression from blood samples.
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 6 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and MS, run by DxTerity Diagnostics at 1 site in United States.
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 5 inclusion and 1 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 6 Aug 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS) (time frame: 2 years). 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 6 Aug 2024.