Exploring the mechanism of action of low-dose glucocorticoids: a study of oral versus parenteral glucocorticoids.

• Conditions: polymyalgia rheumatica; psoriatic arthritis; Reumatoid arthritis; 10023213

• Registration Number: NL-OMON49468
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

-Reumatoid arthritis, polymyalgia rheumatica or psoriatic arthritis according
to the treating physician
-Elevated ESR (>=30 mm/h)

Exclusion Criteria

Difficult to measure a decreased ESR
-Current or recent (<4 weeks previously) on any form of GC therapy, including
topical use
-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 immediate (change of) treatment, 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 giant cell arteritis (according to the treating physician)

Unable or unwilling to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is ESR.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are C-reactive protein (CRP), cortisol, adrenocorticotropic<br /><br>hormone (ACTH) and disease activity (based on Rapid3 questionnaire). Stored<br /><br>serum samples may be used for further analysis of inflammatory cytokines as<br /><br>exploratory endpoints.</p><br>