Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis

NCT01615991 | Completed Phase 3 DMC

• 1 other identifier: CIMS-2012-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy

  Clinical response post treatment

Study Arms (1)

radiosynoviorthesis with yttrium-90 or rhenium -186

OTHER

Patients suffering from arthritis or chronic inflammatory joint disease.

Drug: Radiosynoviorthesis

Interventions

Radiosynoviorthesis DRUG

Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint

Also known as: Yttrium-90 colloid suspension for local injection

radiosynoviorthesis with yttrium-90 or rhenium -186

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead

Study Sites (9)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Lion's Gate Hospital

Vancouver, British Columbia, V7L 2L1, Canada

Location

Health Science Centre

Winnipeg, Manitoba, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher

Longueuil, Quebec, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

CHR Trois-Rivières

Trois-Rivières, Quebec, Canada

Location

Centre Hospitalier Universitaire de Québec

Québec, Canada

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Eric Turcotte, MD

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Clinical research, Centre d'imagerie moléculaire de Sherbrooke; Associate Professor, Université de Sherbrooke;Nuclear Medecine Specialist

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: June 11, 2012
• Study Start: May 31, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

CA (9)