NCT03841279

Brief Summary

MRI has been shown to be helpful in identifying patients who present with undifferentiated inflammatory arthritis who will develop RA within a one year follow up period. The absence of other clinically apparent symptoms often causes delays in diagnosis of RA. The use of the MRI in conjunction with the physical examination has the potential to reduce diagnostic delay. Earlier diagnosis would allow for earlier treatment implementation for better patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2023

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

February 12, 2019

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Earlier Diagnosis of RA if MRI is utilized

    To determine if MRI is predictive of later development of RA in patients with undifferentiated inflammatory arthritis; patients with inflammatory arthritis who receive an MRI will have earlier initiation of treatment

    1 year

Interventions

MRIDIAGNOSTIC_TEST

Magnetic resonance imaging (MRI) produces detailed images of the body's internal structures without relying on radiation. It is used to diagnose and also gauge efficacy of treatment.

Eligibility Criteria

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

The target population for this study will be patients with undifferentiated inflammatory arthritis or seronegative rheumatoid arthritis from the outpatient practice of the Division of Rheumatology in Rochester, MN.

You may qualify if:

  • ≥ 18 years old
  • Undifferentiated inflammatory arthritis suspected to be early RA (≥1 joint with synovitis and ≥1 other tender joint)
  • Symptom duration ≤1 year

You may not qualify if:

  • Unwillingness or inability to return to Mayo Clinic Rochester for research follow-up visits
  • Current or previous use of DMARDS
  • Taking ≥10 mg of prednisone a day
  • Contraindications to contract enhanced MRI
  • History of another definite autoimmune or inflammatory rheumatic disease
  • History of psoriasis
  • History of inflammatory bowel disease
  • Unsuitably as deemed by the principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kerry Wright, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 15, 2019

Study Start

January 1, 2019

Primary Completion

June 17, 2023

Study Completion

December 31, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations