An Observational Study of Patients With Autoimmune Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autoimmune Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
TARGET-AUTOIMMUNE is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .
Primary outcome measures
- 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 outcome measures (3)
- To evaluate provider management practices in the treatment of patients with autoimmune diseases [Time frame: 15 Years]
- To evaluate longitudinal and patient reported outcomes in patients with autoimmune diseases [Time frame: 15 Years]
- To select and evaluate quality of care measures for patients with autoimmune diseases [Time frame: 15 Years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05842824 · TARGET-AUTOIMMUNE