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

Primary Purpose

Arthritis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Radiosynoviorthesis
Sponsored by
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's Hospital
  • Lion's Gate Hospital
  • Health Science Centre
  • Southlake Regional Health Centre
  • Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher
  • Centre hospitalier de l'Université de Montréal
  • Centre hospitalier universitaire de Sherbrooke
  • CHR Trois-Rivières
  • Centre Hospitalier Universitaire de Québec

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

radiosynoviorthesis with yttrium-90 or rhenium -186

Arm Description

Patients suffering from arthritis or chronic inflammatory joint disease.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 14, 2012
Last Updated
April 9, 2021
Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT01615991
Brief Title
Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis
Acronym
RSO
Official Title
Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2012 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiosynoviorthesis with yttrium-90 or rhenium -186
Arm Type
Other
Arm Description
Patients suffering from arthritis or chronic inflammatory joint disease.
Intervention Type
Drug
Intervention Name(s)
Radiosynoviorthesis
Other Intervention Name(s)
Yttrium-90 colloid suspension for local injection
Intervention Description
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
Primary Outcome Measure Information:
Title
safety
Description
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
Secondary Outcome Measure Information:
Title
Efficacy
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Turcotte, MD
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Lion's Gate Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L1
Country
Canada
Facility Name
Health Science Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHR Trois-Rivières
City
Trois-Rivières
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Québec
City
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis

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