A Phase 3 interventional study of Radiosynoviorthesis in Arthritis, sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke. Completed at 9 sites in Canada. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Phase 3, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 300 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Centre de recherche du Centre hospitalier universitaire de Sherbrooke is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients suffering from arthritis or chronic inflammatory joint disease.
Drug: Radiosynoviorthesis
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
Also known as: Yttrium-90 colloid suspension for local injection
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.
Time frame: 3-4 days post -treatment
Efficacy
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.
Time frame: Clinical response post treatment
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Centre de recherche du Centre hospitalier universitaire de Sherbrooke