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

Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Other)
Overall Status
Completed
CT.gov ID
NCT01615991
Collaborator
(none)
300
Enrollment
9
Locations
1
Arm
79
Duration (Months)
33.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 31, 2012
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: radiosynoviorthesis with yttrium-90 or rhenium -186

Patients suffering from arthritis or chronic inflammatory joint disease.

Drug: Radiosynoviorthesis
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
Other Names:
  • Yttrium-90 colloid suspension for local injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. safety [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.

    Secondary Outcome Measures

    1. Efficacy [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alberta Children's Hospital Calgary Alberta Canada
    2 Lion's Gate Hospital Vancouver British Columbia Canada V7L 2L1
    3 Health Science Centre Winnipeg Manitoba Canada
    4 Southlake Regional Health Centre Newmarket Ontario Canada
    5 Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher Longueuil Quebec Canada
    6 Centre hospitalier de l'Université de Montréal Montreal Quebec Canada
    7 Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4
    8 CHR Trois-Rivières Trois-Rivières Quebec Canada
    9 Centre Hospitalier Universitaire de Québec Quebec Canada

    Sponsors and Collaborators

    • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    Investigators

    • Principal Investigator: Eric Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Éric E Turcotte, MD, Head, Clinical research, Centre d'imagerie moléculaire de Sherbrooke; Associate Professor, Université de Sherbrooke;Nuclear Medecine Specialist, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
    ClinicalTrials.gov Identifier:
    NCT01615991
    Other Study ID Numbers:
    • CIMS-2012-01
    First Posted:
    Jun 11, 2012
    Last Update Posted:
    Apr 12, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Arthritis

    Study Results

    No Results Posted as of Apr 12, 2021