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Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03841279
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Kerry Wright, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Diagnostic Test: MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: MRI
    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.

Outcome Measures
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Primary Outcome Measures :
  1. Earlier Diagnosis of RA if MRI is utilized [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

≥ 18 years old

Undifferentiated inflammatory arthritis suspected to be early RA (≥1 joint with synovitis and ≥1 other tender joint)

Symptom duration ≤1 year

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841279


Contacts
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Contact: Kathleen McCarthy-Fruin 507-284-4797 mccarthy1.kathleen@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kathleen McCarthy-Fruin         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kerry Wright, MBBS Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Kerry Wright, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03841279    
Other Study ID Numbers: 18-005455
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases