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An Observational Study of Patients With Autoimmune Disease

Sponsor
Target PharmaSolutions, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05842824
Collaborator
(none)
500,000
Enrollment
187.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    An Observational Study of Patients With Autoimmune Disease
    Anticipated Study Start Date :
    May 24, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2038
    Anticipated Study Completion Date :
    Dec 31, 2038

    Arms and Interventions

    Arm Intervention/Treatment
    Disease Cohort

    Observational
    Engaged Cohort

    Observational

    Outcome Measures

    Primary Outcome Measures

    1. To characterize the natural history of disease in patients with autoimmune disease of various etiologies. [15 Years]

    2. To assess safety and effectiveness of autoimmune disease treatments and treatments for complications of any related conditions [20 Years]

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. To select and evaluate quality of care measures for patients with autoimmune diseases [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Target PharmaSolutions, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Target PharmaSolutions, Inc.
    ClinicalTrials.gov Identifier:
    NCT05842824
    Other Study ID Numbers:
    • TARGET-AUTOIMMUNE
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Autoimmune Diseases

    Study Results

    No Results Posted as of May 6, 2023