Transarterial Embolization Versus Sham Procedure in Adults With Treatment-Resistant Inflammatory Arthritis of a Single Large Joint

NCT ID
NCT07873892
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Istituto Ortopedico Rizzoli
Conditions
Arthritis

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Advancing Discoveries in Vascular Embolization for New Treatments in Rheumatology: a Single-blind, Sham-controlled, Randomized Trial

Enrollment: 30 participants (Estimated).

What is being studied

  • Device: Sham embolization procedure
  • Device: Transarterial embolization with resorbable gelatin microspheres

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Age 18 years or older. * Inflammatory monoarthritis of a large joint (wrist, elbow, shoulder, ankle, knee or hip), fulfilling the ASAS classification criteria for peripheral spondyloarthritis, or diagnosed clinically and on imaging by a rheumatologist when of other aetiology. * Refractoriness to local and pharmacological treatment, defined as failure of both: (a) at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at full dose and for an adequate duration; and (b) at least one intra-articular glucocorticoid injection into the target joint. Patients who have also failed one or more conventional synthetic DMARDs (methotrexate, leflunomide or sulfasalazine) at adequate doses for at least 3 months, and patients with a documented contraindication to starting or continuing systemic immunosuppressive therapy, are also eligible. * Failure of structured physiotherapy. * Pain visual analogue scale (VAS) score of 40 mm or more (0-100 mm scale) at baseline. * Written informed consent. Exclusion Criteria: * Active inflammatory involvement of more than one joint. * Contraindications to angiography: allergy to iodinated contrast medium, severe renal impairment (estimated glomerular filtration rate \<30 mL/min) or uncorrectable coagulopathy. * Intra-articular injection into the target joint within the previous 3 months. * Change in disease-modifying antirheumatic drug (DMARD) therapy within the month before enrollment. * Pregnancy or breastfeeding. * Suspected or confirmed current or previous infection of the target joint. * Known or suspected allergy to porcine gelatin or collagen. * Inability to provide informed consent.

Study locations

No study locations are listed in the registry data.

Study details

Start date
November 1, 2026
Primary completion date
December 1, 2028
Completion date
March 1, 2029
First posted
October 14, 2026
Collaborators
AUSL Bologna

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07873892
Registry last updated
October 14, 2026
QualifiedStudies registry data refreshed
October 19, 2026
QualifiedStudies record fetched
October 19, 2026

View NCT07873892 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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