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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Centre Hospitalier Universitaire de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Dr Éric E Turcotte, MD, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01615991
First received: May 14, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Arthritis
Drug: Radiosynoviorthesis
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Sherbrooke:

Primary Outcome Measures:
  • safety [ Time Frame: 3-4 days post -treatment ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Clinical response post treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Yttrium-90 colloid suspension for local injection

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615991

Contacts
Contact: Helena Senta, PhD 819-346-1110 ext 13660 Helena.Senta@USherbrooke.ca

Locations
Canada, British Columbia
Lion's Gate Hospital Recruiting
Vancouver, British Columbia, Canada, V7L 2L1
Principal Investigator: Philip F Cohen, MD         
Canada, Manitoba
Health Science Centre Recruiting
Winnipeg, Manitoba, Canada
Principal Investigator: Bohdan Bybel, MD         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact    519-685-8500 ext 61395      
Principal Investigator: Jonathan Romsa, MD         
Soothlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada
Contact: Janet Adrian         
Principal Investigator: Carter Thorne, MD         
Canada, Quebec
Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher Recruiting
Longueuil, Quebec, Canada
Principal Investigator: Lucie Carrier, MD         
Centre hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada
Principal Investigator: Michel Picard, MD         
CHS Rimouski-Neigette Recruiting
Rimouski, Quebec, Canada, G5L5T1
Principal Investigator: Daniel Dionne, MD         
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Eric Turcotte, MD         
CHR Trois-Rivières Recruiting
Trois-Rivières, Quebec, Canada
Principal Investigator: Joel Desroches, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Sherbrooke
Investigators
Principal Investigator: Eric Turcotte, MD Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Dr Éric E Turcotte, MD, Head, Clinical research, Centre d'imagerie moléculaire de Sherbrooke; Associate Professor, Université de Sherbrooke;Nuclear Medecine Specialist, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01615991     History of Changes
Other Study ID Numbers: CIMS-2012-01
Study First Received: May 14, 2012
Last Updated: September 24, 2014
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on September 30, 2014