Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis (RSO)
|ClinicalTrials.gov Identifier: NCT01615991|
Recruitment Status : Active, not recruiting
First Posted : June 11, 2012
Last Update Posted : December 4, 2017
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 or disease||Intervention/treatment||Phase|
|Arthritis||Drug: Radiosynoviorthesis||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2018|
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
- safety [ Time Frame: 3-4 days post -treatment ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615991
|Alberta Children's Hospital|
|Calgary, Alberta, Canada|
|Canada, British Columbia|
|Lion's Gate Hospital|
|Vancouver, British Columbia, Canada, V7L 2L1|
|Health Science Centre|
|Winnipeg, Manitoba, Canada|
|Southlake Regional Health Centre|
|Newmarket, Ontario, 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|
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Trois-Rivières, Quebec, Canada|
|Centre Hospitalier Universitaire de Québec|
|Principal Investigator:||Eric Turcotte, MD||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|