Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/30/2018 |
| Start Date: | April 17, 2017 |
| End Date: | October 17, 2021 |
To develop a test to characterize and monitor SLE disease activity status from a
participant's home by analyzing the gene expression from participant self-collected blood
samples using a novel fingerstick collection kit.
participant's home by analyzing the gene expression from participant self-collected blood
samples using a novel fingerstick collection kit.
Systemic lupus erythematosus (SLE or lupus) is a chronic inflammatory autoimmune disorder of
poorly understood etiology associated with a wide range of symptoms and physical findings.
Many patients have incompletely controlled disease progressing to end-stage organ
involvement. Recognizing and predicting flares and under associated organ damage would
facilitate better treatment timing and selection. Recent improvements in care have
dramatically enhanced the survival of lupus patients but increased mortality remains a major
concern and current treatments for lupus remain inadequate. Development of novel therapies to
manage lupus has been hampered by several challenges, including poorly understood
pathogenesis, the heterogeneity of disease activity across and within patient populations,
and difficulties conducting interventional studies. There remains a need for reliable and
timely monitoring of disease activity and degree of organ damage to adequately evaluate
response to treatments and long-term outcome. It is also important to differentiate genuine
lupus activity and flares from another intercurrent disease such as infection.
To fill this gap, panels of reliable biomarkers that can classify patients with lupus into
more homogenous subsets that are linked to disease activity are needed. Such a panel can be
developed from signatures found in lupus patients' transcriptome sequencing data. DxTerity's
proprietary DxCollect® Microcollector Device (MCD) is intended to facilitate the collection,
stabilization, and shipping of a microsample (about 150μL) of blood. This microsample
provides sufficient amounts of quality RNA to perform transcriptome sequencing, allowing
identification and validation of candidate biomarker signatures. A rapid blood test to
monitor and predict disease activity and treatment response would be an innovative diagnostic
product. It could bring significant clinical benefits by enabling the individualized lupus
monitoring and treatment to better control the disease and slow organ damage. This may assist
with unburdening healthcare costs, help identify flares before they happen, and dramatically
improve the management of lupus.
The study will collect participant self-collected blood samples from a fingerstick collection
kit that can be done from home and self-reported information from up to 2500 participants for
analysis.
poorly understood etiology associated with a wide range of symptoms and physical findings.
Many patients have incompletely controlled disease progressing to end-stage organ
involvement. Recognizing and predicting flares and under associated organ damage would
facilitate better treatment timing and selection. Recent improvements in care have
dramatically enhanced the survival of lupus patients but increased mortality remains a major
concern and current treatments for lupus remain inadequate. Development of novel therapies to
manage lupus has been hampered by several challenges, including poorly understood
pathogenesis, the heterogeneity of disease activity across and within patient populations,
and difficulties conducting interventional studies. There remains a need for reliable and
timely monitoring of disease activity and degree of organ damage to adequately evaluate
response to treatments and long-term outcome. It is also important to differentiate genuine
lupus activity and flares from another intercurrent disease such as infection.
To fill this gap, panels of reliable biomarkers that can classify patients with lupus into
more homogenous subsets that are linked to disease activity are needed. Such a panel can be
developed from signatures found in lupus patients' transcriptome sequencing data. DxTerity's
proprietary DxCollect® Microcollector Device (MCD) is intended to facilitate the collection,
stabilization, and shipping of a microsample (about 150μL) of blood. This microsample
provides sufficient amounts of quality RNA to perform transcriptome sequencing, allowing
identification and validation of candidate biomarker signatures. A rapid blood test to
monitor and predict disease activity and treatment response would be an innovative diagnostic
product. It could bring significant clinical benefits by enabling the individualized lupus
monitoring and treatment to better control the disease and slow organ damage. This may assist
with unburdening healthcare costs, help identify flares before they happen, and dramatically
improve the management of lupus.
The study will collect participant self-collected blood samples from a fingerstick collection
kit that can be done from home and self-reported information from up to 2500 participants for
analysis.
Inclusion Criteria:
1. Male and female patients age 18 or older
2. Have a permanent address in the United States for the duration of the study
3. Have an email address and access to the internet for the duration of the study
4. Able to provide informed consent
5. Self-reported diagnosis of lupus
Exclusion Criteria:
1. None
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