GoutNCT02471261
Elastography as Gouty Arthropathy Outcome (EGO)
An observational study of Gout, run by Arthritis & Rheumatism Associates, P.C. at 1 site in United States.
Trial summary
Elastography as Gouty Arthropathy Outcome (EGO), a pilot study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: Elastography as Gouty Arthropathy Outcome (EGO), a Pilot Study.
Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.
Read the detailed description
Pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.
- Conditions
- Gout
- Medical subject headings
- Gout
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastography as Gouty Arthropathy Outcome (EGO), a pilot study
Observational trial to measure gouty arthritis changes in subject taking urate lowering therapies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthritis & Rheumatism Associates, P.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471261
- Sponsor's protocol ID
- ESR-14-10146
- Status last verified
- Oct 2020
- First submitted
- 11 Jun 2015
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastography as Gouty Arthropathy Outcome (EGO), a Pilot Study.
- ClinicalTrials.gov ID
- NCT02471261
- Acronym / sponsor ID
- ESR-14-10146
- Conditions
- Gout
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Arthritis & Rheumatism Associates, P.C.University, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.
Detailed description
Pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.
Key inclusion criteria (4 listed)
- 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.
- -
Key exclusion criteria (4 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Related trials for Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Recruiting
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
Gout, Gouty Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout, run by Arthritis & Rheumatism Associates, P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elastography as Gouty Arthropathy Outcome (EGO), a pilot study (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.