An Observational Study of Patients With Autoimmune Disease

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05842824

Enrollment

500000

Registered

2023-05-06

Start date

2025-03-31

Completion date

2038-12-31

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Disease Cohort Inclusion Criteria: \- Adult patients at the time of enrollment with a diagnosis autoimmune disease by select ICD-10 codes in the EHR interface

Exclusion criteria

* Death * Manual removal (sponsor or site request) * No EHR interface encounter \> 3 years Engaged Cohort Inclusion Criteria: * Adult patients diagnosed and managed for these conditions invited to participate * Ability to provide written informed consent

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
To evaluate provider management practices in the treatment of patients with autoimmune diseases	15 Years	Health care provider type, clinic setting, reason for initiating/not initiating/adjusting dosing of treatments, reason for discontinuing/switching treatments, and monitoring outcomes on and off treatment, will be captured as available in the provided EHR and/or through linked data. Disease-specific quality measures will be selected and evaluated.
To evaluate longitudinal and patient reported outcomes in patients with autoimmune diseases	15 Years	Longitudinal clinical outcomes and disease progression will be assessed. Self-reported patient health measures collect information directly from patients to measure physical, mental, and social health. These measures can help clinicians better understand how the disease state and/or various treatments affect what patients are able to do and the symptoms they experience beyond what is typically derived and reported in the EHR as part of traditional clinical evaluations. The information can also be used to help patients make informed decisions about their healthcare and treatment options.
To select and evaluate quality of care measures for patients with autoimmune diseases	15 Years	1. Identify and select best practices in care of patients with autoimmune diseases 2. Develop a technology infrastructure to evaluate quality measures to support clinicians.

Outcome results