An Observational Study of Patients With Autoimmune Disease

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

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Key information

Conditions

Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Time frame: 15 Years
To assess safety and effectiveness of autoimmune disease treatments and treatments for complications of any related conditions

Time frame: 20 Years

Secondary outcomes

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

Time frame: 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

Time frame: 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

Time frame: 15 Years
- Identify and select best practices in care of patients with autoimmune diseases
- Develop a technology infrastructure to evaluate quality measures to support clinicians.

Sponsors and collaborators

Lead sponsor

Target PharmaSolutions, Inc.

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2038
Study completion: 2038
First posted: May 6, 2023
Registry last updated: Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting