Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
1 other identifier
interventional
159
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2018
CompletedOctober 30, 2017
October 1, 2017
2.5 years
April 30, 2015
October 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
arthritis relapse
6 months
Study Arms (2)
single dose 20 mg
ACTIVE COMPARATORIntraarticular injection of triamcinolone hexacetonide
single dose 40 mg
EXPERIMENTALIntraarticular injection of triamcinolone hexacetonide
Interventions
intraarticular knee injection
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Section of Rheumatology, Gävle hospital
Gävle, 80187, Sweden
Related Publications (10)
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.
PMID: 10700435BACKGROUNDLopes 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.
PMID: 18820311BACKGROUNDPrevoo 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.
PMID: 7818570BACKGROUNDEkdahl 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.
PMID: 3187457BACKGROUNDWeitoft 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.
PMID: 24950951BACKGROUNDLarsen 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
BACKGROUNDArnett 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.
PMID: 3358796BACKGROUNDTaylor 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.
PMID: 16871531BACKGROUNDSTEINBROCKER 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.
PMID: 18150288BACKGROUNDWeitoft 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.
PMID: 30843453DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Tomas Weitoft, MD, PhD
Center for Research and Development Uppsala University/Region Gavleborg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 7, 2015
Study Start
April 1, 2015
Primary Completion
September 30, 2017
Study Completion
June 20, 2018
Last Updated
October 30, 2017
Record last verified: 2017-10