Recruiting

Observational Study

Sponsor:

Lupus Foundation of America

Code:

NCT06927219

Conditions

Systemic Lupus Erythematosus (SLE)

Lupus Nephritis (LN)

Cutaneous Lupus Erythematosus (CLE)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.

Conditions

Systemic Lupus Erythematosus (SLE)

Lupus Nephritis (LN)

Cutaneous Lupus Erythematosus (CLE)

Study ID

NCT06927219

Start date

Oct 1, 2020

Status verified date

Jan, 2026

Completion date

Dec 31, 2050

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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:

  • People who are not living with lupus

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Functional Assessment of Chronic Illness Therapy-Fatigue Scale [ Time Frame: Over a 10 year period ]
  • Work Productivity and Activity Impairment [ Time Frame: Over a 10 year period. ]

Central Contacts and Locations

Central contacts

Joy N Buie, PhD, MSCR, BSN

202-924-4818buie@lupus.org

Daniel McSkimming, PhD

202-349-1155mcskimming@lupus.org

Locations

Online Registry - No Physical Site Required

Recruiting

Washington D.C., District of Columbia, United States, 20037

More Information

Sponsor

Lupus Foundation of America

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • lupus
  • registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Lupus Foundation of America on 2026-01-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.