Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03965676 |
Other study ID # |
P180451 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 24, 2019 |
Est. completion date |
October 11, 2023 |
Study information
Verified date |
March 2023 |
Source |
Assistance Publique - Hôpitaux de Paris |
Contact |
Bousson Valérie, PhD |
Phone |
+33149959106 |
Email |
valerie.bousson[@]aphp.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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