Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseases
Phase 1
- Conditions
- Psoriatic arthritis and rheumatoid arthritis with synovitis of the kneeTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-000993-20-SE
- Lead Sponsor
- Center for Research and Development Uppsala University/County Council of Gävleborg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;Secondary Objective: Not applicable;Primary end point(s): Recurrence of knee symptoms and confirmed synovitis on a clinical examination ;Timepoint(s) of evaluation of this end point: At relapse , during visits according to clinical routines and a phone call after 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable