Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Criteria

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