Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis (RSO)

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Status and phase: Completed; Phase 3

Conditions: Arthritis

Treatments: Drug: Radiosynoviorthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT01615991

CIMS-2012-01

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

radiosynoviorthesis with yttrium-90 or rhenium -186

Other group

Description:

Patients suffering from arthritis or chronic inflammatory joint disease.

Treatment:

Drug: Radiosynoviorthesis