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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
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
-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
NameTimeMethod
ESR
Secondary Outcome Measures
NameTimeMethod
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.
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