An Observational Study of Patients With Autoimmune Disease

Not yet recruiting

• Conditions: Autoimmune Diseases

• Registration Number: NCT05842824
• Lead Sponsor: Target PharmaSolutions, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Study Start: 2025-03-31
• Primary Completion: 2038-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.