Clinical trial NCT02437461: Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
Official title: Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arthritis of the Knee
Keywords: knee synovitis
triamcinolone hexacetonide
treatment response
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: Inclusion Criteria: synovitis of the knee, rheumatoid arthritis or psoriatic arthrthritis, written informed consent

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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

Primary outcomes:
measure: arthritis relapse
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gavle
country: Sweden
facility: Section of Rheumatology, Gävle hospital
Study officials:
affiliation: Center for Research and Development Uppsala University/Region Gavleborg
name: Tomas Weitoft, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.