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

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ClinicalTrials.gov Identifier: NCT02437461
Recruitment Status : Active, not recruiting
First Posted : May 7, 2015
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Weitoft, 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.

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 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


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




Primary Outcome Measures :
  1. arthritis relapse [ Time Frame: 6 months ]


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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

Information from the National Library of Medicine

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
Sweden
Section of Rheumatology, Gävle hospital
Gavle, Sweden, 80187
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Tomas Weitoft, MD, PhD Center for Research and Development Uppsala University/Region Gavleborg

Publications:
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

Responsible Party: Thomas Weitoft, MD, PhD, Uppsala University
ClinicalTrials.gov Identifier: NCT02437461     History of Changes
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:
Synovitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
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