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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26487
Enrollment
35
Registered
2019-08-19
Start date
2019-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis

Interventions

Patients will be randomized to initiate a 4-day course of low dose GC therapy either via the oral or the parenteral route, and then cross over to 4 days via the other route. Before starting this proof

Sponsors

VUmc
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
ESR

Secondary

MeasureTime frame
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.

Contacts

Public ContactLinda Hartman

VUmc

l.hartman@amsterdamumc.nl020-4442485

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)