Rheumatoid ArthritisRABERNCT07914907
GenAI-Assisted Rheumatoid Arthritis Bone Erosion Risk Assessment and DMARD Selection
A study testing GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed RA patients meeting American College of Rheumatology / European League Against Rheumatism 2010 classification criteria
- Consecutive inpatients admitted during study period
Who cannot join
- Patients subsequently determined not to have RA
- Incomplete clinical data preventing risk or treatment assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- 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
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection
- Keywords
- RA bone erosion risk, GenAI prediction, LLMs, DMARD, real-world data, real-world evidence, learning health system unit, GenAI-assisted clinical decision support
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD SelectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GenAI-Assisted RA Bone Erosion Risk Assessment and DMARD Selection | Experimental | 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. Receives: Other: GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Change in Physician-Assessed Rheumatoid Arthritis Bone Erosion Risk Level After GenAI-Assisted Decision Support
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.
Measured: 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
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.
Measured: During index hospitalization, at pre-AI and post-AI physician assessments (approximately 1-7 days)
Secondary outcomes (1)
Cohen's Kappa Agreement Between Physician DMARD Treatment Selection Categories and the Reference Standard After GenAI-Assisted Decision Support
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.
Measured: During index hospitalization, after physician review of the GenAI report (approximately 1-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914907
- Sponsor's protocol ID
- 2026-667-KY-01-raber1
- Other IDs
- CI2023C019YL, CI2026A01501, HLCMHPP2023087, 82230121
- Acronym
- RABER
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Generative AI-Augmented Clinical Decision-Making for Rheumatoid Arthritis Bone Erosion Risk (RABER) Assessment and DMARD Selection in Routine Care
- ClinicalTrials.gov ID
- NCT07914907
- Acronym / sponsor ID
- RABER / 2026-667-KY-01-raber1
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA bone erosion risk, GenAI prediction, LLMs, DMARD, real-world data, real-world evidence, learning health system unit, GenAI-assisted clinical decision support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GenAI-Assisted RA Bone Erosion Risk Assessment and DMARD Selection | Experimental | Other: GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD SelectionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed RA patients meeting American College of Rheumatology / European League Against Rheumatism 2010 classification criteria
- Consecutive inpatients admitted during study period
Key exclusion criteria (2 listed)
- Patients subsequently determined not to have RA
- Incomplete clinical data preventing risk or treatment assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD SelectionThe 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. | Other | GenAI-Assisted RA Bone Erosion Risk Assessment and DMARD Selection |
Primary outcome
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.
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Jiang, MD (010-88001942, doctorjq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.