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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