Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
Information source: Uppsala University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis of the Knee
Intervention: Triamcinolone hexacetonide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Uppsala University Official(s) and/or principal investigator(s): Tomas Weitoft, MD, PhD, Principal Investigator, Affiliation: Center for Research and Development Uppsala University/Region Gavleborg
Overall contact: Tomas Weitoft, MD, PhD, Phone: +46 26 154000, Ext: 4388, Email: thomas.weitoft@regiongavleborg.se
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.
Clinical Details
Official title: Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: arthritis relapse
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: synovitis of the knee, rheumatoid arthritis or psoriatic arthrthritis,
written informed consent
-
Exclusion Criteria:
- 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
Locations and Contacts
Tomas Weitoft, MD, PhD, Phone: +46 26 154000, Ext: 4388, Email: thomas.weitoft@regiongavleborg.se
Section of Rheumatology, Gävle hospital, Gavle 80187, Sweden; Recruiting Tomas Weitoft, MD, PhD, Phone: +46 26 154000, Ext: 4388, Email: thomas.weitoft@regiongavleborg.se Kajsa Öberg, MD, Email: kajsa.oberg@ltdalarna.se
Additional Information
Related publications: Weitoft T, Uddenfeldt P. Importance of synovial fluid aspiration when injecting intra-articular corticosteroids. Ann Rheum Dis. 2000 Mar;59(3):233-5. Lopes 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. Prevoo 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. Ekdahl 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. Weitoft T, Rönnelid 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. Larsen 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. Taylor 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. STEINBROCKER O, TRAEGER CH, BATTERMAN RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949 Jun 25;140(8):659-62.
Starting date: April 2015
Last updated: May 7, 2015
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