Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis

Study Overview
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Brief Summary
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Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is considered a reliable and easy-to-perform therapy without harmful side-effects for the treatment of inflammatory joint disease in many countries. The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide synovectomy are appropriate therapeutic interventions in patients with persistent active synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to systemic therapy and intra-articular corticosteroid injections. The primary objective will be to assess the safety of an intra-articular administration of Yttrium-90 citrate colloid or Rhenium-186 sulfide. The secondary objective will be to assess the efficacy on synovitis.

Official Title
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Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide

Conditions
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Arthritis

Intervention / Treatment
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* Drug: Radiosynoviorthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: There is no age limit for RSO Patient referred by a medical joint specialist (orthopedist, rheumatologist or internal medicine in the absence of local joint specialist) Patient having a refractory inflammatory articular disease: Failure of medical therapy after 6 months Clinical signs of an active mono or oligo synovitis Joint X-ray, echo or MR showing minimal cartilage or bone destruction Pain limits normal activities or requires significant analgesic medication Exclusion Criteria: Prior RSO within last 3 months in that joint Collapse of the articular plateau or intra-articular fracture Surgery or arthroscopy within last 6 weeks Painful prosthesis Joint infection, local skin infection, bacteremia Joint puncture within last 2 weeks (increased risk of soft tissue necrosis along the needle track) Pregnancy or breast feeding Synovial cyst rupture Massive hemarthrosis Generalized synovitis defined as more than 5 uncontrolled joints by clinical examination or 3 phases bone scan Surgical synovectomy within 6months Cancer with bone metastases Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent Participation in any other ongoing clinical trial for the underlying inflammatory condition
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: radiosynoviorthesis with yttrium-90 or rhenium -186<br>Patients suffering from arthritis or chronic inflammatory joint disease. | Drug: Radiosynoviorthesis<br>* Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint<br>* Other names: Yttrium-90 colloid suspension for local injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | The safety profile will be assessed by the incidence of AEs. All the AEs will be described by system/organ class and preferred terms and overall sorted by frequency. | 3-4 days post -treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Efficacy outcomes will be the clinical response over 1 year post treatment ( at 3, 6 and 12 months):The comparison will be done with a confidence interval approach based on a Chi²-test for each of the above secondary criterion assessed at different times during the follow-up compared to the same criterion assessed at baseline. | Clinical response post treatment |