nravelling the mechanism of action of low-dose glucocorticoids: a study of oral versus parenteral glucocorticoids.
- Conditions
- Reumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis
- Registration Number
- NL-OMON26487
- Lead Sponsor
- VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 35
Reumatoid arthritis, polymyalgia rheumatica or psoriatic arthritis according to the treating physician
-Elevated ESR (=30 mm/h)
Difficult to measure a decreased ESR
-Current or recent (<4 weeks previously) on any form of GC therapy
-For reumatoid arthritis and psoriatic arthritis patients, change of antirheumatic medication (DMARDs, biologics) in the 4 weeks before the assessment
-Known with other health conditions that can cause elevated ESR (e.g. hematologic disorders, infections, multiple myeloma, monoclonal gammopathy etc.)
Risk of harm
-Active disease necessitating (change of) treatment within weeks, according to treating physician
-Unstable medical condition causing contra-indication for GC, according to treating physician. For example active infection, unstable diabetes, malignant hypertension, etc.
-Signs or symptoms of temporal arteritis (according to the treating physician)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ESR
- Secondary Outcome Measures
Name Time Method C-reactive protein (CRP), cortisol, adrenocorticotropic hormone (ACTH) and disease activity (based on Rapid3 questionnaire). Stored serum samples may be used for further analysis of inflammatory cytokines as exploratory endpoints.