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

Phase 4

• Conditions: Arthritis of the Knee
• Interventions: Drug: Triamcinolone hexacetonide

• Registration Number: NCT02437461
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-07
• Primary Completion: 2017-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30
• Study Completion: 2018-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single dose 40 mg	Triamcinolone hexacetonide	Intraarticular injection of triamcinolone hexacetonide
single dose 20 mg	Triamcinolone hexacetonide	Intraarticular injection of triamcinolone hexacetonide

Primary Outcome Measures

Name	Time	Method
arthritis relapse	6 months

Trial Locations

Locations (1)

Section of Rheumatology, Gävle hospital; 🇸🇪 Gavle, Sweden