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Clinical Trials/NCT05842824
NCT05842824Not yet recruitingNot Applicable

An Observational Study of Patients With Autoimmune Disease

Target PharmaSolutions, Inc.0 sites500,000 target enrollmentStarted: March 31, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
500,000
Primary Endpoint
To characterize the natural history of disease in patients with autoimmune disease of various etiologies.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •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

Outcomes

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 select and evaluate quality of care measures for patients with autoimmune diseases(15 Years)
  • To evaluate provider management practices in the treatment of patients with autoimmune diseases(15 Years)
  • To evaluate longitudinal and patient reported outcomes in patients with autoimmune diseases(15 Years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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