NCT02471261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

June 11, 2015

Last Update Submit

October 22, 2020

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

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

    Observational trial to measure gouty arthritis changes in subject taking urate lowering therapies

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Subjects who are at least 18 years of age but younger than or equal to 99 years of age.
  • Subjects with gouty arthritis as determined by the ACR 1977 classification criteria for gouty arthritis.
  • Subjects with one palpable tophus detectable by one of the three clinical parameters described.

You may not qualify if:

  • Subjects who are not eligible for urate lowering treatment or show a hypersensitivity to these drugs or class of compounds.
  • 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.
  • Subjects for which the clinical and laboratory assessment would provide undue discomfort and / or are contraindicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 15, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations

US(1)