Clinical trial NCT01615991: Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis
Official title: Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: safety
timeFrame: 3-4 days post -treatment
Secondary outcomes:
measure: Efficacy
timeFrame: Clinical response post treatment
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Lion's Gate Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Science Centre
state: Manitoba
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Longueuil
country: Canada
facility: Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher
state: Quebec
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Trois-Rivières
country: Canada
facility: CHR Trois-Rivières
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier Universitaire de Québec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Eric Turcotte, MD
role: PRINCIPAL_INVESTIGATOR
References: