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Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis (RSO)

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ClinicalTrials.gov Identifier: NCT01615991
Recruitment Status : Active, not recruiting
First Posted : June 11, 2012
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

May 14, 2012
June 11, 2012
December 4, 2017
May 2012
December 31, 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01615991 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis
Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide

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.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthritis
Drug: Radiosynoviorthesis
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
Other Name: Yttrium-90 colloid suspension for local injection
radiosynoviorthesis with yttrium-90 or rhenium -186
Patients suffering from arthritis or chronic inflammatory joint disease.
Intervention: Drug: Radiosynoviorthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
1500
December 31, 2018
December 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01615991
CIMS-2012-01
Yes
Not Provided
Not Provided
Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Not Provided
Principal Investigator: Eric Turcotte, MD Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP