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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis
• Intervention / Treatment: Drug: Radiosynoviorthesis

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • Centre Hospitalier Universitaire de Quebec
  • Alberta
    • Calgary, Alberta, Canada
      • Alberta Children's Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V7L 2L1
      • Lion's Gate Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Health Science Centre
  • Ontario
    • Newmarket, Ontario, Canada
      • Southlake Regional Health Centre
  • Quebec
    • Longueuil, Quebec, Canada
      • Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher
    • Montreal, Quebec, Canada
      • Centre Hospitalier de l'Université de Montréal
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
    • Trois-Rivières, Quebec, Canada
      • CHR Trois-Rivières

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Investigators: Principal Investigator: Eric Turcotte, MD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: May 31, 2012
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 11, 2012

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: CIMS-2012-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No