An Observational Study of Patients With Autoimmune Disease

April 11, 2024 updated by: Target PharmaSolutions, Inc.
TARGET-AUTOIMMUNE is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Disease Cohort
Observational
Engaged Cohort
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize the natural history of disease in patients with autoimmune disease of various etiologies.
Time Frame: 15 Years
15 Years
To assess safety and effectiveness of autoimmune disease treatments and treatments for complications of any related conditions
Time Frame: 20 Years
20 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 Years
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.
15 Years
To select and evaluate quality of care measures for patients with autoimmune diseases
Time Frame: 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.
15 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Target PharmaSolutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 31, 2038

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET-AUTOIMMUNE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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