Arthritis of the KneePhase 4NCT02437461
Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
A Phase 4 study testing Triamcinolone hexacetonide in people with Arthritis of the Knee, run by Uppsala University at 1 site in Sweden.
Trial summary
This prospective randomised controlled single blind trial comparing the relapse rate in 6 months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (Lederspan®) for knee synovitis in patients with rheumatoid arthritis (RA) and psoriatic artritis (PsoA) is performed to find the optimal dose to use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis of the Knee
- What is being tested?
- Triamcinolone hexacetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2015to 20 Jun 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- inability to understand study information, function class 4 according to Steinbrocker, planning knee surgery, , joint infection, intraarticular glucocorticoid injection in this joint the past 3 months, oral glucocortoid treatment corresponding to >10 mg prednisolone
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomised controlled single blind trial comparing the relapse rate in 6 months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (Lederspan®) for knee synovitis in patients with rheumatoid arthritis (RA) and psoriatic artritis (PsoA) is performed to find the optimal dose to use.
Read the detailed description
Background:
Triamcinolone hecacetonide (THA) has been used for local intraarticular injecton treatment for knee synovitis in decades, but no dose finding studies have been performed. In the literature the doses for knee injections vary between 20 mg and 80 mg, depending on local traditions.
The aim of the present study is to find the optimal THA dosing, comparing the relapse rate during a 6 month observation period for the two most used dosages .
Methods:
Adult patients with RA or PsoA with treatment demands for ongoing knee synovitis are recruited at the Rheumatology Departments in Gävle and Falun. After informed consent patient characteristics,(age, sex, medical treatment), clinical and laboratory parameters of disease activity (DAS28, CRP), as well as degree of functional impairment (HAQ) are collected. A radiographic examination of the knee is performed and assessed (using Larsen Dale index) by an independent radiologist. The patients are allocated to either 20 mg or 40 mg THA using the randomisation dose which is hidden in prepared closed envelopes. After complete synovial fluid aspiration the THA dose is injected . The patients are told to contact the rheumatology department if no treatment response or if symtoms from the treated knee recurr. If so, the knee is examined again and if synovitis is confirmed a relapse is registered. Time from injection to relapse is calculated. Patients without relapse are called after 6 months to confirm they still are well and that no unknown relapse have occurred. When the observation period for the last included patient is finished the relapse rate between the 20 mg THA group is compared with the 40 mg THA Group.
- Conditions
- Arthritis of the Knee
- Being tested
- Triamcinolone hexacetonide
- Keywords
- knee synovitis, triamcinolone hexacetonide, treatment response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone hexacetonideDrug
Also called Lederspan
intraarticular knee injection
| Study group | Role | What they receive |
|---|---|---|
| single dose 20 mg | Active comparator | Intraarticular injection of triamcinolone hexacetonide Receives: Drug: Triamcinolone hexacetonide |
| single dose 40 mg | Experimental | Intraarticular injection of triamcinolone hexacetonide Receives: Drug: Triamcinolone hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
arthritis relapse
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startApr 2015
- Primary completion30 Sep 2017
- Study completion20 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Arthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Weitoft, Uppsala University
- Investigators
- Tomas Weitoft, MD, PhD, Principal investigator, Center for Research and Development Uppsala University/Region Gavleborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437461
- Sponsor's protocol ID
- TW77
- Status last verified
- Oct 2017
- First submitted
- 30 Apr 2015
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weitoft T, Uddenfeldt P. Importance of synovial fluid aspiration when injecting intra-articular corticosteroids. Ann Rheum Dis. 2000 Mar;59(3):233-5. doi: 10.1136/ard.59.3.233.
PubMed 10700435Lopes RV, Furtado RN, Parmigiani L, Rosenfeld A, Fernandes AR, Natour J. Accuracy of intra-articular injections in peripheral joints performed blindly in patients with rheumatoid arthritis. Rheumatology (Oxford). 2008 Dec;47(12):1792-4. doi: 10.1093/rheumatology/ken355. Epub 2008 Sep 27.
PubMed 18820311Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
PubMed 7818570Ekdahl C, Eberhardt K, Andersson SI, Svensson B. Assessing disability in patients with rheumatoid arthritis. Use of a Swedish version of the Stanford Health Assessment Questionnaire. Scand J Rheumatol. 1988;17(4):263-71. doi: 10.3109/03009748809098795.
PubMed 3187457Weitoft T, Ronnelid J, Knight A, Lysholm J, Saxne T, Larsson A. Outcome predictors of intra-articular glucocorticoid treatment for knee synovitis in patients with rheumatoid arthritis - a prospective cohort study. Arthritis Res Ther. 2014 Jun 20;16(3):R129. doi: 10.1186/ar4586.
PubMed 24950951Larsen A, Dale K. Standardized radiological examination of rheumatoid arthritis in therapeutical trials. In Dumonde DC, Jasani MK, eds. The recognition of antirheumatic drugs. Lancaster: MTP Press, 1978: 285-292
Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.
PubMed 3358796Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73. doi: 10.1002/art.21972.
PubMed 16871531STEINBROCKER O, TRAEGER CH, BATTERMAN RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949 Jun 25;140(8):659-62. doi: 10.1001/jama.1949.02900430001001. No abstract available.
PubMed 18150288Weitoft T, Oberg K. Dosing of intra-articular triamcinolone hexacetonide for knee synovitis in chronic polyarthritis: a randomized controlled study. Scand J Rheumatol. 2019 Jul;48(4):279-283. doi: 10.1080/03009742.2019.1571222. Epub 2019 Mar 7.
PubMed 30843453
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
- ClinicalTrials.gov ID
- NCT02437461
- Acronym / sponsor ID
- TW77
- Conditions
- Arthritis of the Knee
- Keywords
- knee synovitis, triamcinolone hexacetonide, treatment response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 20 Jun 2018 (estimated)
- First posted
- 7 May 2015 (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.
This prospective randomised controlled single blind trial comparing the relapse rate in 6 months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (Lederspan®) for knee synovitis in patients with rheumatoid arthritis (RA) and psoriatic artritis (PsoA) is performed to find the optimal dose to use.
Detailed description
Background:
Triamcinolone hecacetonide (THA) has been used for local intraarticular injecton treatment for knee synovitis in decades, but no dose finding studies have been performed. In the literature the doses for knee injections vary between 20 mg and 80 mg, depending on local traditions.
The aim of the present study is to find the optimal THA dosing, comparing the relapse rate during a 6 month observation period for the two most used dosages .
Methods:
Adult patients with RA or PsoA with treatment demands for ongoing knee synovitis are recruited at the Rheumatology Departments in Gävle and Falun. After informed consent patient characteristics,(age, sex, medical treatment), clinical and laboratory parameters of disease activity (DAS28, CRP), as well as degree of functional impairment (HAQ) are collected. A radiographic examination of the knee is performed and assessed (using Larsen Dale index) by an independent radiologist. The patients are allocated to either 20 mg or 40 mg THA using the randomisation dose which is hidden in prepared closed envelopes. After complete synovial fluid aspiration the THA dose is injected . The patients are told to contact the rheumatology department if no treatment response or if symtoms from the treated knee recurr. If so, the knee is examined again and if synovitis is confirmed a relapse is registered. Time from injection to relapse is calculated. Patients without relapse are called after 6 months to confirm they still are well and that no unknown relapse have occurred. When the observation period for the last included patient is finished the relapse rate between the 20 mg THA group is compared with the 40 mg THA Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single dose 20 mg | Active comparator | Drug: Triamcinolone hexacetonideIntraarticular injection of triamcinolone hexacetonide |
| single dose 40 mg | Experimental | Drug: Triamcinolone hexacetonideIntraarticular injection of triamcinolone hexacetonide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- inability to understand study information, function class 4 according to Steinbrocker, planning knee surgery, , joint infection, intraarticular glucocorticoid injection in this joint the past 3 months, oral glucocortoid treatment corresponding to >10 mg prednisolone
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 |
|---|---|---|
| Triamcinolone hexacetonideAlso: Lederspanintraarticular knee injection | Drug | single dose 20 mg, single dose 40 mg |
Primary outcome
arthritis relapse
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Background: PubMed 10700435Weitoft T, Uddenfeldt P. Importance of synovial fluid aspiration when injecting intra-articular corticosteroids. Ann Rheum Dis. 2000 Mar;59(3):233-5. doi: 10.1136/ard.59.3.233.
- Background: PubMed 18820311Lopes RV, Furtado RN, Parmigiani L, Rosenfeld A, Fernandes AR, Natour J. Accuracy of intra-articular injections in peripheral joints performed blindly in patients with rheumatoid arthritis. Rheumatology (Oxford). 2008 Dec;47(12):1792-4. doi: 10.1093/rheumatology/ken355. Epub 2008 Sep 27.
- Background: PubMed 7818570Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
- Background: PubMed 3187457Ekdahl C, Eberhardt K, Andersson SI, Svensson B. Assessing disability in patients with rheumatoid arthritis. Use of a Swedish version of the Stanford Health Assessment Questionnaire. Scand J Rheumatol. 1988;17(4):263-71. doi: 10.3109/03009748809098795.
- Background: PubMed 24950951Weitoft T, Ronnelid J, Knight A, Lysholm J, Saxne T, Larsson A. Outcome predictors of intra-articular glucocorticoid treatment for knee synovitis in patients with rheumatoid arthritis - a prospective cohort study. Arthritis Res Ther. 2014 Jun 20;16(3):R129. doi: 10.1186/ar4586.
- BackgroundLarsen A, Dale K. Standardized radiological examination of rheumatoid arthritis in therapeutical trials. In Dumonde DC, Jasani MK, eds. The recognition of antirheumatic drugs. Lancaster: MTP Press, 1978: 285-292
- Background: PubMed 3358796Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.
- Background: PubMed 16871531Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73. doi: 10.1002/art.21972.
- Background: PubMed 18150288STEINBROCKER O, TRAEGER CH, BATTERMAN RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949 Jun 25;140(8):659-62. doi: 10.1001/jama.1949.02900430001001. No abstract available.
- Derived from this study: PubMed 30843453Weitoft T, Oberg K. Dosing of intra-articular triamcinolone hexacetonide for knee synovitis in chronic polyarthritis: a randomized controlled study. Scand J Rheumatol. 2019 Jul;48(4):279-283. doi: 10.1080/03009742.2019.1571222. Epub 2019 Mar 7.
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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.
Tomas Weitoft, MD, PhD principal investigator
Center for Research and Development Uppsala University/Region Gavleborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone hexacetonide in people with Arthritis of the Knee, run by Uppsala University at 1 site in Sweden.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
arthritis relapse (time frame: 6 months). 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 NCT02437461, which also lists 10 linked publications.
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 30 Oct 2017.