Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis (RSO)
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 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|
- 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.
- 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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
radiosynoviorthesis with yttrium-90 or rhenium -186
Patients suffering from arthritis or chronic inflammatory joint disease.
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
Other Name: Yttrium-90 colloid suspension for local injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615991
|Canada, British Columbia|
|Lion's Gate Hospital|
|Vancouver, British Columbia, Canada, V7L 2L1|
|Health Science Centre|
|Winnipeg, Manitoba, Canada|
|Centre de santé de des services sociaux Drummond, Hôpital Sainte-Croix|
|Drummondville, Quebec, 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|
|Rimouski, Quebec, Canada, G5L5T1|
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Trois-Rivières, Quebec, Canada|
|Principal Investigator:||Eric Turcotte, MD||Centre Hospitalier Universitaire de Sherbrooke|