Systemic Lupus Erythematosus (SLE)RAYNCT06927219
Research Accelerated by You Lupus Registry
An observational study of Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by Lupus Foundation of America at 1 site in United States.
Trial summary
Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Cutaneous Lupus Erythematosus (CLE)
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Dec 2050
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People diagnosed with systemic lupus erythematosus, lupus nephritis (lupus-related kidney disease), Cutaneous lupus erythematosus (CLE) or discoid lupus erythematosus (DLE)
Who may be able to join
- For adults with lupus, the individual who completes the Registry:
- is 18 years of age or older
- has a self-reported diagnosis of lupus by a physician or health care provider
- is willing and able to provide informed consent
- is able to read and understand English sufficiently to complete the survey questions
- has access to a computer with an internet connection
Show all 18Show fewer
- For children under 18 with lupus, the individual who completes the Registry is:
- 18 years of age or older
- the parent/legal guardian/legally authorized representative of a child under 18 years of age that has a diagnosis of lupus by a physician or health care provider
- willing and able to provide consent for the child under 18 years of age and to obtain assent from the child between 7-17 years of age
- able to access a computer with an internet connection
- able to read and understand English sufficiently to complete the survey questions
- For adults with lupus unable to provide consent, the individual who completes the Registry is:
- 18 years of age or older
- the legally authorized representative of an adult 18 or older who is unable to provide consent and has a diagnosis of lupus by a physician or health care provider
- willing and able to provide consent for the adult with lupus
- able to access a computer with an internet connection
- able to read and understand English sufficiently to complete the survey questions
Who cannot join
- People who are not living with lupus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Online Registry - No Physical Site Required
Washington D.C., District of Columbia, 20037
About this study
Official title: Web-Based Data Collection Through the Research Accelerated by You (RAY) Lupus Registry
Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. The primary goal is to better understand the diagnosis, treatment, care, and quality of life for those affected by the disease.
Remote Participation This is a decentralized, online-only registry. Participation is conducted entirely through a secure web-based portal. There are no physical site visits or travel requirements; participants can contribute from any location with internet access.
Read more
Participation Details
Consent: Informed consent is completed electronically.
Surveys: Participants complete electronic surveys upon enrollment and every six months thereafter.
Data Types: Collected data is self-reported and includes demographics, diagnosis history, treatment information, and patient-reported outcomes (PROs), such as quality of life.
Purpose and Data Use The LFA uses registry data to:
Address Constituent Needs: Inform programs and resources for the lupus community.
Advance Research: Share patient insights with to ensure therapies are developed with the consideration of what matters and what matters most to people living with lupus.
Patient Engagement and Clinical Research Matching: Participants may be contacted to assess eligibility for patient engagement or clinical research opportunities or to complete specific sub-surveys regarding trial participation.
Read the detailed description
This is a multinational, direct-to-patient registry available to patients in the United States and Canada. The registry will enroll 10,000 people living with lupus who have a diagnosis of:
- Systemic Lupus Erythematosus
- Lupus Nephritis (Lupus Related Kidney Disease)
- Skin-Only Lupus (Cutaneous Lupus)
- Skin-Only Lupus With Scarring (Discoid Lupus)
- Lupus Caused By Medication(S) (Drug-Induced Lupus)
The registry will include questions about demographics, diagnostic journey, signs and symptoms, treatments, impact of lupus on health and quality of life, patient report outcomes and preferences related to clinical trials. The registry will also collect information about fatigue and work productivity.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Cutaneous Lupus Erythematosus (CLE)
- Keywords
- lupus, registry
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Lupus Erythematosus, Cutaneous
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 |
|---|---|---|
| Lupus Patients | This is an observational study of people living with systemic lupus erythematosus, lupus nephritis, cutaneous lupus erythematosus or a mixture of these diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Chronic Illness Therapy-Fatigue Scale
This 13-item scale measures self-report fatigue and impacts on activities of daily living and functioning. The scale as been validated in various disease areas including cancer patients, cancer survivors, rheumatoid arthritis and systemic lupus erythematosus.
Measured: Over a 10 year period
Work Productivity and Activity Impairment
This outcome measure evaluates impairments over the past 7 days in both paid and unpaid work due to an individual\'s health.
Measured: Over a 10 year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Oct 2020
- Primary completion30 Sep 2030 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lupus Foundation of America
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joy N Buie, PhD, MSCR, RN, Principal investigator, Lupus Foundation of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927219
- Sponsor's protocol ID
- Pro00020515
- Acronym
- RAY
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2025
- Last updated
- 23 Jan 2026
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Data Collection Through the Research Accelerated by You (RAY) Lupus Registry
- ClinicalTrials.gov ID
- NCT06927219
- Acronym / sponsor ID
- RAY / Pro00020515
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Cutaneous Lupus Erythematosus (CLE)
- Keywords
- lupus, registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Lupus Foundation of AmericaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 15 Apr 2025 (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.
Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. The primary goal is to better understand the diagnosis, treatment, care, and quality of life for those affected by the disease.
Remote Participation This is a decentralized, online-only registry. Participation is conducted entirely through a secure web-based portal. There are no physical site visits or travel requirements; participants can contribute from any location with internet access.
Participation Details
Consent: Informed consent is completed electronically.
Surveys: Participants complete electronic surveys upon enrollment and every six months thereafter.
Data Types: Collected data is self-reported and includes demographics, diagnosis history, treatment information, and patient-reported outcomes (PROs), such as quality of life.
Purpose and Data Use The LFA uses registry data to:
Address Constituent Needs: Inform programs and resources for the lupus community.
Advance Research: Share patient insights with to ensure therapies are developed with the consideration of what matters and what matters most to people living with lupus.
Patient Engagement and Clinical Research Matching: Participants may be contacted to assess eligibility for patient engagement or clinical research opportunities or to complete specific sub-surveys regarding trial participation.
Detailed description
This is a multinational, direct-to-patient registry available to patients in the United States and Canada. The registry will enroll 10,000 people living with lupus who have a diagnosis of:
- Systemic Lupus Erythematosus
- Lupus Nephritis (Lupus Related Kidney Disease)
- Skin-Only Lupus (Cutaneous Lupus)
- Skin-Only Lupus With Scarring (Discoid Lupus)
- Lupus Caused By Medication(S) (Drug-Induced Lupus)
The registry will include questions about demographics, diagnostic journey, signs and symptoms, treatments, impact of lupus on health and quality of life, patient report outcomes and preferences related to clinical trials. The registry will also collect information about fatigue and work productivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupus Patients | – | –This is an observational study of people living with systemic lupus erythematosus, lupus nephritis, cutaneous lupus erythematosus or a mixture of these diseases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People diagnosed with systemic lupus erythematosus, lupus nephritis (lupus-related kidney disease), Cutaneous lupus erythematosus (CLE) or discoid lupus erythematosus (DLE)
Key inclusion criteria (18 listed)
- For adults with lupus, the individual who completes the Registry:
- 18 years of age or older
- the parent/legal guardian/legally authorized representative of a child under 18 years of age that has a diagnosis of lupus by a physician or health care provider
- willing and able to provide consent for the child under 18 years of age and to obtain assent from the child between 7-17 years of age
- able to access a computer with an internet connection
Key exclusion criteria (1 listed)
- People who are not living with lupus
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
Functional Assessment of Chronic Illness Therapy-Fatigue Scale
Time frame: Over a 10 year period
This 13-item scale measures self-report fatigue and impacts on activities of daily living and functioning. The scale as been validated in various disease areas including cancer patients, cancer survivors, rheumatoid arthritis and systemic lupus erythematosus.
Work Productivity and Activity Impairment
Time frame: Over a 10 year period.
This outcome measure evaluates impairments over the past 7 days in both paid and unpaid work due to an individual\'s health.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- 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.
Joy N Buie, PhD, MSCR, RN principal investigator
Lupus Foundation of America
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 Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by Lupus Foundation of America 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 18 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joy N Buie, PhD, MSCR, BSN (202-924-4818, buie@lupus.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (time frame: Over a 10 year period). 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 23 Jan 2026.