Clinical trial NCT06927219: Research Accelerated by You Lupus Registry
Official title: Web-Based Data Collection Through the Research Accelerated by You (RAY) Lupus Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus (SLE)
Lupus Nephritis (LN)
Cutaneous Lupus Erythematosus (CLE)
Keywords: lupus
registry
Lead sponsor: Lupus Foundation of America
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People diagnosed with systemic lupus erythematosus, lupus nephritis (lupus-related kidney disease), Cutaneous lupus erythematosus (CLE) or discoid lupus erythematosus (DLE)

Brief summary: The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is an ongoing, voluntary, longitudinal study gathers data from adults with lupus and legally authorized representatives of children with lupus to better understand diagnosis, treatment, care, and quality of life. Participants provide informed consent and complete electronic surveys every six months. The LFA uses the data to address constituent needs, share clinical research opportunities, and advance lupus research by sharing de-identified data with approved third-party investigators. The LFA will promote participation via its website and email outreach to around 200,000 people connected to lupus. Participants may also be resurveyed to assess clinical trial eligibility and other factors related to trial participation. Types of self-reported data will include: demographics, diagnoses, treatment information and patient reported outcomes, including quality of life reports, which have been increasingly recognized as essential for assessing health outcomes.


Eligibility criteria: Inclusion Criteria:

* 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

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

Exclusion Criteria:

-

Primary outcomes:
measure: Functional Assessment of Chronic Illness Therapy-Fatigue Scale
timeFrame: Over a 10 year period
measure: Work Productivity and Activity Impairment
timeFrame: Over a 10 year period.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lupus Foundation of America
state: District of Columbia
Study officials:
affiliation: Lupus Foundation of America
name: Joy N Buie, PhD, MSCR, RN
role: PRINCIPAL_INVESTIGATOR
References: