NCT06715488

Brief Summary

The investigators are testing the ability of convolutional neural networks (CNNs), that is artificial intelligence, on smartphone photographs in detecting inflammatory arthritis. This promises to be an efficient, accurate, and non-invasive diagnostic tool that will significantly improve early detection and management of inflammatory arthritis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Nov 2024Dec 2027

Study Start

First participant enrolled

November 15, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

November 28, 2024

Last Update Submit

December 19, 2024

Conditions

Keywords

Artificial intelligence for arthritis diagnosis

Outcome Measures

Primary Outcomes (1)

  • Accuracy of AI diagnosis against specialist (rheumatologist) opinion

    Concordance of detection of synovitis by convolutional neural network (binary) with a clinically diagnosed specialist opinion (rheumatologist opinion)

    3 years

Secondary Outcomes (2)

  • Accuracy of AI diagnosis against imaging diagnosis on Ultrasound

    3 years

  • Sensitivity to change

    3 years

Study Arms (1)

Inflammatory arthritis

Patients with inflammatory arthritis regardless of etiology including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis and viral arthritis

Diagnostic Test: AI assisted smartphone diagnosis

Interventions

Patients will examination and clinical photographs for convolutional networks to diagnose inflammatory arthritis

Inflammatory arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with inflammatory arthritis. This can include but is not limited to rheumatoid arthritis, lupus, psoriatic arthritis, peripheral spondyloarthritis, viral arthritis.

You may qualify if:

  • Inflammatory arthritis of any etiology

You may not qualify if:

  • Severe deformity that hampers standardization of photographs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rheumatology Clinic

Pune, Maharashtra, 411004, India

Location

Poona Superspeciality Clinic

Pune, 411001, India

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sanat Phatak, MD, DM

    Med2Measure

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

November 15, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Deidentified photographs and clinical information excluding HIPAA variables

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
January 2027-January 2028
Access Criteria
Researchers with a scientific plan can get in touch with the principal investigator with a brief note.

Locations