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Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response

Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03316404
Acronym
EMPOWER
Enrollment
1168
Registered
2017-10-20
Start date
2017-11-07
Completion date
2020-02-25
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS, Multiple Sclerosis

Keywords

Multiple Sclerosis, MS

Brief 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.

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.

Interventions

None listed

Sponsors

DxTerity Diagnostics
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)2 yearsObtain 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026