Lupus Erythematosus, SystemicReLATENCT05845593
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
An observational study of Lupus Erythematosus, Systemic, run by Ampel BioSolutions, LLC at 11 sites in United States.
Trial summary
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Decision Support Test
- How many people
- 200 participants
- Where
- 11 sitesUnited States
- Study dates
- 19 Dec 2023to 5 Mar 2025
- 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: Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus
Who may be able to join
- Male or female aged at least 18 years old.
- Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
- Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
- On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing
Who cannot join
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk
- Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
- Pregnant or lactating.
- Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer
- Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Vinh Nguyen, 410-706-6474, BSIATON@SOM.UMARYLAND.EDU
Violeta Rus
- Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207
Audrey Droppelman, 704-631-3342 ext. 1170, adroppelman@aocc.md
Gordon Lam
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Joshlean Fair, 312-942-8268, Joshlean_Fair@rush.edu
Meenakshi Jolly
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Sandra Hodnick, 216-444-6039, hodnics@ccf.org
Emily Littlejohn
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Carla Martinez, 310-360-9197, carla@walleemed.com
Daniel Wallace
- Recruiting
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Sanita Kandasami, 516-562-2401, skandasami@northwell.edu
Cynthia Aranow
- Not yet recruiting
Yale School of Medicine
New Haven, Connecticut, 06519
Julie Heffernan, 203-785-6631, julie.heffernan@yale.edu
Fotios Koumpouras
- Not yet recruiting
The Hospital for Special Surgery
New York, New York, 10021
Emily Wu, 212-774-2967, wue@hss.edu
Kyriakos Kirou
- Not yet recruiting
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032
Rebecca Martinez, 480-350-7655, rebecca.martinez@azarthritis.com
Hani Rashid
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55096
Amber Woltzen, 507-422-6732, woltzen.amber@mayo.edu
Uma Thanarajasingam
- Not yet recruiting
Providence St. John's Health Center - Rheumatology
Santa Monica, California, 90404
Olga Pimienta, 310-449-1999, olga.pimienta@providence.org
Orrin Troum
About this study
Official title: An Open Label Multicenter Study to Assess the Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With Systemic Lupus Erythematosus (SLE)
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Decision Support Test
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support TestOther
LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus Receives: Other: Decision Support Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
LuGENE clinical decision support relative to clinical disease activity
The primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical activity (SLEDAI score) Physician Global Assessment (PGA).
Measured: 16 months
LuGENE clinical decision support relative to lab measures
The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE® with standard laboratory measures of lupus (ANA, anti-DNA, anti-RNP and complement components C3 and C4)
Measured: 16 months
LuGENE clinical decision support relative to PROs
The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE with standard evaluation of patient reported outcomes using standard instruments capturing pain, fatigue and Health-Related Quality of Life.
Measured: 16 months
Secondary outcomes (9)
LuGENE score correlation to Immune Function with Biomarker endpoint:
The association of the LuGENE Score with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).
Measured: 16 months
LuGENE score correlation to Clinical Feature endpoint:
The association of the LuGENE Score with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)
Measured: 16 months
LuGENE score correlation to Quality of Life PROs endpoint:
The association of the LuGENE Score with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))
Measured: 16 months
LuGENE subset membership correlation to Immune Function with Biomarker endpoint:
The association of the LuGENE® determined subset membership with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).
Measured: 16 months
LuGENE subset membership correlation to Clinical Feature endpoint:
The association of the LuGENE® determined subset membership with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)
Measured: 16 months
LuGENE subset membership correlation to Quality of Life PROs endpoint:
The association of the LuGENE® determined subset membership with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))
Measured: 16 months
LuGENE profile correlation to Immune Function with Biomarker endpoint:
The association of the LuGENE® profile with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).
Measured: 16 months
LuGENE profile correlation to Clinical Feature endpoint:
The association of the LuGENE® profile with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)
Measured: 16 months
LuGENE profile correlation to Quality of Life PROs endpoint:
The association of the LuGENE® profile with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start19 Dec 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion5 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ampel BioSolutions, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845593
- Sponsor's protocol ID
- AMP-005
- Acronym
- ReLATE
- Status last verified
- May 2024
- First submitted
- 4 Apr 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hubbard EL, Bachali P, Kingsmore KM, He Y, Catalina MD, Grammer AC, Lipsky PE. Analysis of transcriptomic features reveals molecular endotypes of SLE with clinical implications. Genome Med. 2023 Oct 16;15(1):84. doi: 10.1186/s13073-023-01237-9.
PubMed 37845772
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multicenter Study to Assess the Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT05845593
- Acronym / sponsor ID
- ReLATE / AMP-005
- Conditions
- Lupus Erythematosus, Systemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ampel BioSolutions, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 5 Mar 2025 (estimated)
- First posted
- 6 May 2023 (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.
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Decision Support TestAdult male and female patients with a clinical diagnosis of SLE or incomplete lupus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus
Key inclusion criteria (4 listed)
- Male or female aged at least 18 years old.
- Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
- Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
- On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing
Key exclusion criteria (6 listed)
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk
- Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
- Pregnant or lactating.
- Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer
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 |
|---|---|---|
| Decision Support TestLuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE | Other | Group 1 |
Primary outcome
LuGENE clinical decision support relative to clinical disease activity
Time frame: 16 months
The primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical activity (SLEDAI score) Physician Global Assessment (PGA).
LuGENE clinical decision support relative to lab measures
Time frame: 16 months
The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE® with standard laboratory measures of lupus (ANA, anti-DNA, anti-RNP and complement components C3 and C4)
LuGENE clinical decision support relative to PROs
Time frame: 16 months
The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE with standard evaluation of patient reported outcomes using standard instruments capturing pain, fatigue and Health-Related Quality of Life.
9 secondary outcomes
LuGENE score correlation to Immune Function with Biomarker endpoint:
Time frame: 16 months
LuGENE score correlation to Clinical Feature endpoint:
Time frame: 16 months
LuGENE score correlation to Quality of Life PROs endpoint:
Time frame: 16 months
LuGENE subset membership correlation to Immune Function with Biomarker endpoint:
Time frame: 16 months
LuGENE subset membership correlation to Clinical Feature endpoint:
Time frame: 16 months
LuGENE subset membership correlation to Quality of Life PROs endpoint:
Time frame: 16 months
LuGENE profile correlation to Immune Function with Biomarker endpoint:
Time frame: 16 months
LuGENE profile correlation to Clinical Feature endpoint:
Time frame: 16 months
LuGENE profile correlation to Quality of Life PROs endpoint:
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 37845772Hubbard EL, Bachali P, Kingsmore KM, He Y, Catalina MD, Grammer AC, Lipsky PE. Analysis of transcriptomic features reveals molecular endotypes of SLE with clinical implications. Genome Med. 2023 Oct 16;15(1):84. doi: 10.1186/s13073-023-01237-9.
- Related InfoLink provided by the sponsor.
- 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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic, run by Ampel BioSolutions, LLC at 11 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Dykas (434-296-2675, claire.dykas@ampelbiosolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LuGENE clinical decision support relative to clinical disease activity (time frame: 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05845593, which also lists 1 linked publication.
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 3 May 2024.