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Elastography as Gouty Arthropathy Outcome (EGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471261
Recruitment Status : Unknown
Verified June 2015 by Arthritis & Rheumatism Associates, P.C..
Recruitment status was:  Recruiting
First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Arthritis & Rheumatism Associates, P.C.

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

Condition or disease
Gout

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

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Elastography as Gouty Arthropathy Outcome (EGO), a Pilot Study.
Study Start Date : May 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Joint Disorders




Primary Outcome Measures :
  1. Elastography as Gouty Arthropathy Outcome (EGO), a pilot study [ Time Frame: 1 year ]
    Observational trial to measure gouty arthritis changes in subject taking urate lowering therapies



Information from the National Library of Medicine

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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:   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.
Criteria

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.

    -

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.

    -


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): NCT02471261


Locations
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United States, Maryland
The Center for Rheumatology and Bone Research Recruiting
Wheaton, Maryland, United States, 20902
Contact: Theresa Bass-Goldman    301-942-6610    tbgoldman@arapc.com   
Principal Investigator: Paul J DeMarco, MD         
Sub-Investigator: Alan K Matsumoto, MD         
Sub-Investigator: Herbert S Baraf, MD         
Sub-Investigator: Robert L Rosenberg, MD         
Sub-Investigator: Evan L Siegel, MD         
Sub-Investigator: Ashley D Beall, MD         
Sub-Investigator: Nicole Sadddic-Thomas, MD         
Sponsors and Collaborators
Arthritis & Rheumatism Associates, P.C.
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Responsible Party: Arthritis & Rheumatism Associates, P.C.
ClinicalTrials.gov Identifier: NCT02471261    
Other Study ID Numbers: ESR-14-10146
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases