Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis

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ClinicalTrials.gov Identifier: NCT02437461

Recruitment Status : Unknown

Verified October 2017 by Thomas Weitoft, Uppsala University.
Recruitment status was: Active, not recruiting

First Posted : May 7, 2015

Last Update Posted : October 30, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Thomas Weitoft, Uppsala University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Arthritis of the Knee	Drug: Triamcinolone hexacetonide	Phase 4

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	159 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
Actual Study Start Date :	April 2015
Actual Primary Completion Date :	September 30, 2017
Estimated Study Completion Date :	June 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

Genetic and Rare Diseases Information Center resources: Synovitis Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: single dose 20 mg Intraarticular injection of triamcinolone hexacetonide	Drug: Triamcinolone hexacetonide intraarticular knee injection Other Name: Lederspan
Experimental: single dose 40 mg Intraarticular injection of triamcinolone hexacetonide	Drug: Triamcinolone hexacetonide intraarticular knee injection Other Name: Lederspan

Outcome Measures

Primary Outcome Measures :

arthritis relapse [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437461

Locations

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Sweden
Section of Rheumatology, Gävle hospital
Gavle, Sweden, 80187

Sponsors and Collaborators

Uppsala University

Investigators

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Principal Investigator:	Tomas Weitoft, MD, PhD	Center for Research and Development Uppsala University/Region Gavleborg

More Information

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.

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. doi: 10.1002/art.1780380107.

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. doi: 10.3109/03009748809098795.

Weitoft 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.

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. doi: 10.1002/art.1780310302.

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. doi: 10.1002/art.21972.

STEINBROCKER 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Weitoft 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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Responsible Party:	Thomas Weitoft, MD, PhD, Uppsala University
ClinicalTrials.gov Identifier:	NCT02437461
Other Study ID Numbers:	TW77
First Posted:	May 7, 2015 Key Record Dates
Last Update Posted:	October 30, 2017
Last Verified:	October 2017

Keywords provided by Thomas Weitoft, Uppsala University:


knee synovitis triamcinolone hexacetonide treatment response

Additional relevant MeSH terms:

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Arthritis Synovitis Joint Diseases Musculoskeletal Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Triamcinolone diacetate Anti-Inflammatory Agents	Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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