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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthritis of the Knee

Intervention / Treatment
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* Drug: Triamcinolone hexacetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single dose 20 mg<br>Intraarticular injection of triamcinolone hexacetonide | Drug: Triamcinolone hexacetonide<br>* intraarticular knee injection<br>* Other names: Lederspan;|
| Experimental: single dose 40 mg<br>Intraarticular injection of triamcinolone hexacetonide | Drug: Triamcinolone hexacetonide<br>* intraarticular knee injection<br>* Other names: Lederspan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arthritis relapse |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee synovitis, triamcinolone hexacetonide, treatment response