Elastography as Gouty Arthropathy Outcome (EGO)

Elastography as Gouty Arthropathy Outcome (EGO), a Pilot Study.

Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.

Study Overview

• Status: Completed
• Conditions: Gout

Detailed Description

Pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.

Description

Inclusion Criteria:

1. Subjects who are at least 18 years of age but younger than or equal to 99 years of age.
2. Subjects with gouty arthritis as determined by the ACR 1977 classification criteria for gouty arthritis.

3. Subjects with one palpable tophus detectable by one of the three clinical parameters described.

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Exclusion Criteria:

1. Subjects who are not eligible for urate lowering treatment or show a hypersensitivity to these drugs or class of compounds.
2. Subjects with significant cardiovascular, neuropsychiatric, hematologic, hepatic, renal or endocrine dysfunction who in the opinion of the principal investigator are unfit for participation in a clinical trial.

3. Subjects for which the clinical and laboratory assessment would provide undue discomfort and / or are contraindicated.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elastography as Gouty Arthropathy Outcome (EGO), a pilot study	Observational trial to measure gouty arthritis changes in subject taking urate lowering therapies	1 year

Collaborators and Investigators

• Sponsor: Arthritis & Rheumatism Associates, P.C.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: ESR-14-10146