Research into continuation or cessation of urate lowering therapies in gout patients in remission.

Phase 1

• Conditions: Gout, arthritis urica; MedDRA version: 20.0Level: PTClassification code 10018627Term: GoutSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-005730-15-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

To be eligible to participate in this study, a participant must meet all of the following criteria:
- Patients with clinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR gout criteria
-Use of ULT (allopurinol, benzbromarone and/or febuxostat)
-Achieved remission for = 12 months based on adapted preliminary gout remission criteria
oFree of flares and/or clinically apparent tophi during the last 12 months
oSerum urate =0.36 mmol/l at baseline and all values in the last 12 months should not be >0.36 mmol/l
oPain due to gout <2 using a 10-point Likert-type scale at baseline
oPatient global assessment of gout disease activity <2 using a 10-point Likert-type scale at baseline
-Age =18 years and mentally competent
-Signed written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

A potential participant will be excluded from participation in this study if one of the following criteria has been met:
-Not being able to speak, read or write Dutch well enough
-No ability to measure the outcome of the study in the participant (e.g. life expectancy <2 years, planned relocation out of reach of study center)
-A strong contra-indication for glucocorticoids, NSAIDs AND colchicine, as this hampers flare treatment
-Use of ULT (also) for any other indication than gout (for example nephrolithiasis)
-Currently taking regular glucocorticoids, and/or colchicine, and/or interleukine-1 inhibitors for any diagnosis and/or the use of regular NSAID intake for gout activity
-A history of myocardial infarction or stroke in the past six months and/or congestive heart failure NYHA class III or IV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified