Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis

Arthritis Clinical Trial

— RSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615991
• Other study ID #: CIMS-2012-01
• Status: Completed
• Phase: Phase 3
• Start date: May 31, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2021
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis

Intervention

Drug:
• Radiosynoviorthesis
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher	Longueuil	Quebec
Canada	Centre hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Centre Hospitalier Universitaire de Québec	Quebec
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	CHR Trois-Rivières	Trois-Rivières	Quebec
Canada	Lion's Gate Hospital	Vancouver	British Columbia
Canada	Health Science Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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