GenAI-Assisted Rheumatoid Arthritis Bone Erosion Risk Assessment and DMARD Selection (RABER)

October 28, 2026 updated by: Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Prospective Evaluation of Generative AI-Augmented Clinical Decision-Making for Rheumatoid Arthritis Bone Erosion Risk (RABER) Assessment and DMARD Selection in Routine Care

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by progressive joint damage and bone erosion. Accurate assessment of RA bone erosion risk (RABER) and appropriate disease-modifying antirheumatic drug (DMARD) selection are critical to preventing irreversible disability.

Recent advances in generative artificial intelligence (GenAI), particularly large language models (LLMs), enable integration of heterogeneous clinical data and may improve clinical decision-making. However, there is limited real-world evidence (RWE) evaluating whether GenAI can meaningfully augment physician decision-making in routine care.

This prospective, single-arm, nonrandomized interventional study evaluates the feasibility and impact of GenAI-assisted clinical decision support on physician assessment of rheumatoid arthritis bone erosion risk and disease-modifying antirheumatic drug selection in routine inpatient care. Treating physicians document their initial risk assessments and treatment decisions before reviewing patient-specific GenAI reports and subsequently record their assessments and decisions after reviewing the reports. The study evaluates changes in physician clinical decision-making within a learning health system framework. Final treatment decisions remain under the responsibility of the treating physicians. The study does not evaluate long-term patient clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Recruiting
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
        • Contact:
        • Principal Investigator:
          • Quan Jiang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed RA patients meeting American College of Rheumatology / European League Against Rheumatism 2010 classification criteria
  • Consecutive inpatients admitted during study period

Exclusion Criteria:

  • Patients subsequently determined not to have RA
  • Incomplete clinical data preventing risk or treatment assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GenAI-Assisted RA Bone Erosion Risk Assessment and DMARD Selection

This arm will include at least 100 consecutive adult inpatients with rheumatoid arthritis (RA) receiving routine clinical care. For each patient, the treating physician will first independently assess bone erosion risk and select a disease-modifying antirheumatic drug (DMARD) treatment strategy based on available clinical information (pre-AI assessment). The physician will then review a GenAI-generated clinical decision support report containing predicted bone erosion risk levels and DMARD recommendations and record an updated risk assessment and treatment decision (post-AI assessment). Pre-AI and post-AI physician decisions will be compared against independent expert reference standards to evaluate the impact of GenAI-assisted decision support. Treating physicians retain full responsibility for final clinical decisions.
Other: GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection

The intervention consists of a GenAI-generated clinical decision support report provided to treating physicians during routine RA care. Using patient clinical information available at the time of assessment, the GenAI system generates predicted bone erosion risk probabilities (0-100%), risk levels (0-3), and DMARD treatment recommendations. Physicians review the report after completing their independent pre-AI assessments and may revise their risk assessments and treatment decisions based on the additional information. The GenAI system provides decision support only and does not autonomously make or implement treatment decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Change in Physician-Assessed Rheumatoid Arthritis Bone Erosion Risk Level After GenAI-Assisted Decision Support
Time Frame: During index hospitalization, at pre-AI and post-AI physician assessments (approximately 1-7 days)

The percentage of participants for whom the treating physician changes the rheumatoid arthritis bone erosion risk level after reviewing the GenAI-generated clinical decision support report, compared with the initial assessment before reviewing the report. Risk levels are categorized from 0 to 3. A change is defined as any difference between the pre-AI and post-AI risk levels. The percentage is calculated using participants with complete paired assessments.
During index hospitalization, at pre-AI and post-AI physician assessments (approximately 1-7 days)
Cohen's Kappa Agreement Between Physician-Assessed Rheumatoid Arthritis Bone Erosion Risk Levels and the Reference Standard Before and After GenAI-Assisted Decision Support
Time Frame: During index hospitalization, at pre-AI and post-AI physician assessments (approximately 1-7 days)

Agreement between physician-assessed rheumatoid arthritis bone erosion risk levels (0-3) and the reference standard will be evaluated separately before and after review of the GenAI report using Cohen's kappa coefficient. The pre-AI and post-AI kappa coefficients will be compared to assess changes in agreement following GenAI-assisted decision support. Cohen's kappa ranges from -1 to 1, with higher values indicating greater agreement beyond chance. The difference between post-AI and pre-AI kappa coefficients will be reported, with positive values indicating improved agreement. The reference classification will be established during the data analysis stage by three independent expert physicians who are not involved in patient treatment, with disagreements resolved through consensus.
During index hospitalization, at pre-AI and post-AI physician assessments (approximately 1-7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen's Kappa Agreement Between Physician DMARD Treatment Selection Categories and the Reference Standard After GenAI-Assisted Decision Support
Time Frame: During index hospitalization, after physician review of the GenAI report (approximately 1-7 days)

Agreement between physician-selected disease-modifying antirheumatic drug (DMARD) treatment categories (0-4) and the reference standard will be assessed after physicians review the GenAI-generated clinical decision support report. Agreement will be quantified using Cohen's kappa coefficient, with higher values indicating greater agreement beyond chance. The analysis will include participants with complete post-AI physician treatment selections and corresponding reference standard classifications. The reference classification will be established during the data analysis stage by three independent expert physicians who are not involved in patient treatment, with disagreements resolved through consensus.
During index hospitalization, after physician review of the GenAI report (approximately 1-7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 21, 2026

First Submitted That Met QC Criteria

October 28, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 28, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-667-KY-01-raber1
  • CI2023C019YL (Other Grant/Funding Number: China Academy of Chinese Medical Sciences)
  • CI2026A01501 (Other Grant/Funding Number: China Academy of Chinese Medical Sciences)
  • HLCMHPP2023087 (Other Grant/Funding Number: China National Administration of Traditional Chinese Medicine)
  • 82230121 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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