NCT05842824

Brief Summary

TARGET-AUTOIMMUNE is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
154mo left

Started Mar 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2025Dec 2038

First Submitted

Initial submission to the registry

March 9, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Last Updated

November 20, 2024

Status Verified

April 1, 2024

Enrollment Period

13.8 years

First QC Date

March 9, 2023

Last Update Submit

November 18, 2024

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

  • To characterize the natural history of disease in patients with autoimmune disease of various etiologies.

    15 Years

  • To assess safety and effectiveness of autoimmune disease treatments and treatments for complications of any related conditions

    20 Years

Secondary Outcomes (3)

  • To evaluate provider management practices in the treatment of patients with autoimmune diseases

    15 Years

  • To evaluate longitudinal and patient reported outcomes in patients with autoimmune diseases

    15 Years

  • To select and evaluate quality of care measures for patients with autoimmune diseases

    15 Years

Study Arms (2)

Disease Cohort

Observational

Engaged Cohort

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include adults who are being managed for autoimmune disease

You may qualify if:

  • \- Adult patients at the time of enrollment with a diagnosis autoimmune disease by select ICD-10 codes in the EHR interface

You may not qualify if:

  • Death
  • Manual removal (sponsor or site request)
  • No EHR interface encounter \> 3 years
  • Engaged Cohort
  • Adult patients diagnosed and managed for these conditions invited to participate
  • Ability to provide written informed consent
  • Patient expressed desire to withdraw consent to complete PROs
  • Failure to complete PROs within 24 weeks of initial invitation
  • Greater than 24 months lapse of survey completion after baseline surveys completed
  • Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

May 6, 2023

Study Start

March 31, 2025

Primary Completion (Estimated)

December 31, 2038

Study Completion (Estimated)

December 31, 2038

Last Updated

November 20, 2024

Record last verified: 2024-04