An Observational Study of Patients With Autoimmune Disease

Autoimmune Diseases Clinical Trial

Official title:

An Observational Study of Patients With Autoimmune Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05842824
• Other study ID #: TARGET-AUTOIMMUNE
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: December 31, 2038

Study information

• Verified date: April 2024
• Source: Target PharmaSolutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the natural history of disease in patients with autoimmune disease of various etiologies.		15 Years
Primary	To assess safety and effectiveness of autoimmune disease treatments and treatments for complications of any related conditions		20 Years
Secondary	To evaluate provider management practices in the treatment of patients with autoimmune diseases	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.	15 Years
Secondary	To evaluate longitudinal and patient reported outcomes in patients with autoimmune diseases	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.	15 Years
Secondary	To select and evaluate quality of care measures for patients with autoimmune diseases	Identify and select best practices in care of patients with autoimmune diseases; Develop a technology infrastructure to evaluate quality measures to support clinicians.	15 Years