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Rheumatoid Arthritis (RANCT07301892

Generative AI Impact on Rheumatoid Arthritis Complications Diagnosis

An observational study of Rheumatoid Arthritis (RA and Osteoporosis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Any age
What is being tested?
Generative AI prediction report for RA complications
How many people
100 participants
Where
1 siteChina
Study dates
1 Oct 2025to Jun 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Quan Jiang Guang'anmen Hospital, China Academy of Chinese Medical Science contact

010-88001942

doctorjq@126.com

China1 site, 1 recruiting
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality, 100053

    Quan Jiang, MD, 010-88001942, doctorjq@126.com

    Quan Jiang, MD

    Recruiting

Other trials in China

About this study

Official title: Impact of Generative Artificial Intelligence on Diagnosing Rheumatoid Arthritis Complications

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.

Being tested
Generative AI prediction report for RA complications
Keywords
Rheumatoid Arthritis, generative AI, large language model, Rheumatoid arthritis complications
Medical subject headings
Arthritis, Rheumatoid, Osteoporosis, Osteoarthritis, Lung Diseases, Interstitial, Thyroid Diseases, Cardiovascular Diseases, Sjogren's Syndrome, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Generative AI prediction report for RA complicationsOther

    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.

Study groups in NCT07301892
Study groupRoleWhat they receive
RA patient group using generative AI prediction reportsInpatients 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.
Receives: Other: Generative AI prediction report for RA complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  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.

    Measured: Immediately after making the final diagnosis at discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start1 Oct 2025
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07301892
Sponsor's protocol ID
2025-201-KY
Status last verified
Dec 2025
First submitted
28 Sep 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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