ArthritisPhase 3RSONCT01615991
Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis
A Phase 3 study testing Radiosynoviorthesis in people with Arthritis, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis
- What is being tested?
- Radiosynoviorthesis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 9 sitesCanada
- Study dates
- 31 May 2012to 31 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Alberta Children's Hospital
Calgary, Alberta
Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher
Longueuil, Quebec
Centre hospitalier de l'Université de Montréal
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario
Centre Hospitalier Universitaire de Québec
Québec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
CHR Trois-Rivières
Trois-Rivières, Quebec
Lion's Gate Hospital
Vancouver, British Columbia, V7L 2L1
Health Science Centre
Winnipeg, Manitoba
About this study
Official title: 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.
Read more
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.
- Conditions
- Arthritis
- Being tested
- Radiosynoviorthesis
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiosynoviorthesisDrug
Also called Yttrium-90 colloid suspension for local injection
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
| Study group | Role | What they receive |
|---|---|---|
| radiosynoviorthesis with yttrium-90 or rhenium -186 | Other | Patients suffering from arthritis or chronic inflammatory joint disease. Receives: Drug: Radiosynoviorthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 days post -treatment
Secondary outcomes (1)
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.
Measured: Clinical response post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study start31 May 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Investigators
- Eric Turcotte, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615991
- Sponsor's protocol ID
- CIMS-2012-01
- Acronym
- RSO
- Status last verified
- Apr 2021
- First submitted
- 14 May 2012
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Desaulniers M, Paquette M, Dubreuil S, Senta H, Lavallee E, Thorne JC, Turcotte E. Safety and Efficacy of Radiosynoviorthesis: A Prospective Canadian Multicenter Study. J Nucl Med. 2024 Jul 1;65(7):1095-1100. doi: 10.2967/jnumed.123.267297.
PubMed 38754957
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide
- ClinicalTrials.gov ID
- NCT01615991
- Acronym / sponsor ID
- RSO / CIMS-2012-01
- Conditions
- Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- 31 May 2012
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiosynoviorthesis with yttrium-90 or rhenium -186 | Other | Drug: RadiosynoviorthesisPatients suffering from arthritis or chronic inflammatory joint disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiosynoviorthesisAlso: Yttrium-90 colloid suspension for local injectionIntraarticular administration from 111 to 222 Mbq yttrium-90 per joint | Drug | radiosynoviorthesis with yttrium-90 or rhenium -186 |
Primary outcome
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.
1 secondary outcome
Efficacy
Time frame: Clinical response post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Derived from this study: PubMed 38754957Desaulniers M, Paquette M, Dubreuil S, Senta H, Lavallee E, Thorne JC, Turcotte E. Safety and Efficacy of Radiosynoviorthesis: A Prospective Canadian Multicenter Study. J Nucl Med. 2024 Jul 1;65(7):1095-1100. doi: 10.2967/jnumed.123.267297.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Turcotte, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiosynoviorthesis in people with Arthritis, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (time frame: 3-4 days post -treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.