Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis (RSO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|