Evolution of Tophus and Erosions of Hands and Feet at DECT — TOPHERO-CT  

Tophaceous Gout Clinical Trial

Official title: Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography

Status Recruiting

Clinical Trial Summary

The main objective is to evaluate the decrease in crystalline volume of the target tophus using Dual-Energy Computed Tomography (DECT), after 6 months +/- 1 month of urate-lowering therapy with target uricemia.

Study hypothesis

• The dynamics of tophus resolution with urate-lowering therapy is poorly understood.

• It is variable according to the location of the tophus, peri articular / intratendinous, but also probably at the feet / hands, the initial overall volume of the tophus, the initial crystal charge of the tophus. Knowledge of prognostic factors for tophus resolution will help determine the best target for treatment follow-up for each patient.

• Erosions are the consequence of tophus. Tophus resolution could be associated with repair of erosions and stabilization of joint destruction.

Clinical Trial Description

Study design The research is a non-randomized prospective bi-centric study in adult patients with tophaceous gout. It aims at studying tophus resolution (main objective), and prognostic factors for tophus resolution (secondary objective), and bone erosions, with Dual-Energy Computed Tomography (DECT) (secondary objective).

Study population

• Adult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia < 360µmol/L).

• Recruitment of patients during a visit or hospitalization in rheumatology at Lariboisière Hospital.

Calculated size of study population: 50 patients

No control group

Inclusion criteria

• Age greater than or equal to 18 years

• Patient with a tophaceous gout

• Without urate-lowering treatment or with treatment but uricemia not at target

• Having given its free and informed consent to participate in this study

• Affiliated with a social security system

Non-Inclusion criteria

• Pregnant or breastfeeding woman

• Participation in another intervention research or period of exclusion due to a previous research.

• Impossibility to position oneself in ventral position (position for hands/wrists DECT acquisition).

Acts or product added for the research study Dual-Energy Computed Tomography examination at 6 and 12 months +/- 1 month of medical treatment with uricemia < 360µmol/L (baseline DECT is in the domain of usual care).

For each patient, 3 visits (usual care):

• M0: Inclusion visit

• M6 + /- 1 month: visit, usual care, + DECT for research purpose

• M12 + /- 1 month: visit, usual care, + DECT for research purpose

Research duration:

• Inclusion period: 24 months

• Duration of participation (treatment + follow-up): 12 months + /- 1 month

• Total duration: 37 months ;

Related Conditions & MeSH terms

• Tophaceous Gout

• NCT number: NCT03965676
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bousson Valérie, PhD
• Phone: +33149959106
• Email: valerie.bousson@aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2019
• Completion date: October 11, 2023