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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	5 February 2018
Main ID:	EUCTR2014-000993-20-SE
Date of registration:	02/09/2014
Prospective Registration:	Yes
Primary sponsor:	Center for Research and Development Uppsala University/County Council of Gävleborg
Public title:	Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseases
Scientific title:	Dosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritis
Date of first enrolment:	04/12/2014
Target sample size:	160
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000993-20
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Higher dose of IMP Number of treatment arms in the trial: 2
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
Sweden

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Age > 18 years
chronic polyarthritis (psoriatic arthritis or rheumatoid arthritis)
Synovitis of the knee
acceptance to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
prednisolone >10mg daily
intraarticular glucocorticoid injection in this joint the past 3 months
untreated ongoing infection
severely disabled
knee joint surgery performed or planned for this joint
inability to understand study information

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriatic arthritis and rheumatoid arthritis with synovitis of the knee

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: triamcinolone hexacetonide (Lederspan)
Product Name: triamcinolone hexacetonid (Lederspan)
Product Code: 9512
Pharmaceutical Form: Injection

Trade Name: triamcinolone hexacetonide (Lederspan)
Product Name: triamcinolone hexacetonid (Lederspan)
Product Code: 9512
Pharmaceutical Form: Injection

Primary Outcome(s)

Main Objective: To study the relapse rate after intraaarticular triamcinolone hexacetonide (20 vs 40 mg) treatment for knee synovitis in patients with rheumatoid arthritis and psoriatic arthritis

Timepoint(s) of evaluation of this end point: At relapse , during visits according to clinical routines and a phone call after 6 months

Primary end point(s): Recurrence of knee symptoms and confirmed synovitis on a clinical examination

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

TW77

Source(s) of Monetary Support

Center for Research and Development Uppsala University/County Council of Gävleborg

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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