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RecruitingNCT07301892Updated Dec 24, 2025

Generative AI Impact on Rheumatoid Arthritis Complications Diagnosis

An observational study in Rheumatoid Arthritis (RA, Osteoporosis and Osteoarthritis, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Sex
All
01

Study summary

Generative AI (GenAI) based on large language models (LLMs) is expected to improve the diagnosis and treatment of autoimmune diseases. We are studying how GenAI may affect the diagnosis of various complications of rheumatoid arthritis (RA). In a retrospective study using RA patients' EHR records, we will quantify physician adoption of GenAI predictions for RA complications and co-existing diseases. In a prospective observational study, we will assess the feasibility of using GenAI predictions as additional clinical information to help physicians make more complete diagnoses of RA complications and co-existing diseases, including complex, uncommon, or rare conditions.

02

Conditions studied

  • Rheumatoid Arthritis (RA
  • Osteoporosis
  • Osteoarthritis
  • Interstitial Lung Disease
  • Thyroid Diseases
  • Cardiovascular Diseases
  • Pulmonary Complications
  • Sjogren's Syndrome
  • Liver Disorders
  • Renal Lesions
  • Vasculitis
  • Amyloidosis
  • Peripheral Neuropathy
  • Thrombosis
  • RA Complications

Keywords

  • Rheumatoid Arthritis
  • generative AI
  • large language model
  • Rheumatoid arthritis complications
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult male and female RA inpatients admitted to our Rheumatology Department who fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification and diagnostic criteria for rheumatoid arthritis.

Inclusion criteria

  • Patients with an initial diagnosis of rheumatoid arthritis (RA).
  • All real-world RA inpatients admitted to our department.
  • Admission occurring within the real-world data study period.

Exclusion criteria

Exclusion Criteria:

  • Patients subsequently confirmed not to have RA during the study.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • RA patient group using generative AI prediction reports

    Inpatients newly diagnosed with rheumatoid arthritis in our rheumatology department between October 1, 2025, and June 2026 will be recruited for the study. Physicians will use GenAI predictions of potential RA complications and co-existing diseases, together with confirmatory diagnostic tests, as additional inputs in the differential diagnosis process.

    Other: Generative AI prediction report for RA complications

Interventions

  • OtherGenerative AI prediction report for RA complications

    Generative AI based on multiple large language models (LLMs) is used to predict potential complications and co-existing diseases in patients with rheumatoid arthritis using EHR data available at admission. Physicians use these AI predictions as additional information to adjust their diagnostic plans during differential diagnosis. The impact of this intervention on the final diagnoses at discharge will be measured. Before the prospective study, the adoptability of the generative AI prediction reports will be validated using EHR records from retrospective RA patients.

05

What researchers measure

Primary outcomes

  1. Will physicians adopt GenAI predictions in diagnosing RA complications?

    In the routine care workflow, large language models (LLMs) are used to predict potential RA complications for each de-identified patient case and generate an AI report listing possible complications and co-existing diseases. Additional diagnostic tests are suggested to verify the predicted conditions. After reviewing the AI report, physicians immediately evaluate each disease prediction using a 5-point Likert scale (1 = complete disagreement; 2 = disagreement; 3 = neutral; 4 = agreement; 5 = complete agreement). The mean score is calculated as a measure of perceived prediction accuracy. Physicians also indicate whether each specific disease prediction could potentially be adopted or used to assist differential diagnosis (binary: 0 or 1). The percentage of positive adoption responses is calculated as a measure of potential adoption rate, or adoptability.

    Time frame: Immediately after reviewing patient AI report on the day of admission.

Secondary outcomes

  1. To what extent are RA complication diagnoses actually affected by GenAI predictions?

    Before patient discharge, physicians make final diagnoses and record which diagnosed complications or co-existing diseases were influenced by GenAI prediction information for each patient. The percentage of cases in which GenAI predictions affected the final diagnosis is calculated as a measure of AI's actual impact on routine diagnostic practice.

    Time frame: Immediately after making the final diagnosis at discharge.

06

Study locations

1 of 1 sites recruiting
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Beijing, Beijing Municipality 100053, China
    • Quan Jiang, MD · Contact · doctorjq@126.com · 010-88001942
    • Quan Jiang, MD · Principal investigator
    Recruiting
07

References and documents

08

Registry details

Key details

Study ID
NCT07301892
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Responsible party
Quan Jiang (Director of the Rheumatology Department, Guang'anmen Hospital of China Academy of Chinese Medical Sciences) — Principal investigator
First posted
Dec 24, 2025
Start date
Oct 1, 2025
Primary completion
Feb 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Dec 24, 2025

Study contacts

Quan Jiang Guang'anmen Hospital, China Academy of Chinese Medical Science
Contact
doctorjq@126.com
010-88001942

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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