Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05479448
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2022-07-26
Brief Title:
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR andor GCA It evaluates the association of endogenous GC suppression plasma and urinary cortisol and cortisone to the responsiveness of PMRGCA to GCs
Detailed Description:
Polymyalgia rheumatica PMR and giant cell arteritis GCA are closely related inflammatory rheumatic diseases The first-line treatment of both PMR and GCA are glucocorticoids GC In PMR initial oral prednisone equivalent doses in between 10 and 25 mgday are given In contrast GCA is usually treated with significantly higher steroid doses starting dose 1 mgkg body-weight to prevent vascular complications
The dose and duration of steroid treatment needed to control disease in patients with PMR and GCA vary and about half of the patients experience relapses early upon GC dose tapering or after discontinuation of treatment The reasons for the inter-individual differences in steroid-response are not known Data from this controlled prospective study will help to identify subjects with GC resistance which would allow to use intensified treatment strategies higher dose or alternative immune modulatory therapy to overcome resistance On the other hand strong responsiveness to GC would provide a rational for rapid steroid tapering or treatment with lower doses both resulting in reduced risk for GC related adverse events such as osteoporosis infections diabetes and mood disorders Detailed understanding of the relation of individual GC signaling and GC metabolism with patients response to steroid treatment will help to define steroid responder profiles This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR andor GCA
At inclusion and at all follow-up visits the clinical evaluation will be documented in the SCQM database All participants with PMR will be treated according to our local treatment protocol starting dose is 15 mg prednisoned tapered by 25 mg every second week once symptoms are controlled After tapering to 10 mgd prednisone dose is further reduced by 25 mg every month
All patients with GCA are treated according to published guidelines with prednisone starting at 1mgkg body-weight followed by reduction to 0 mg at week 26 GIACTA protocol
The dose and duration of steroid treatment needed to control disease in patients with PMR and GCA vary and about half of the patients experience relapses early upon GC dose tapering or after discontinuation of treatment The reasons for the inter-individual differences in steroid-response are not known Data from this controlled prospective study will help to identify subjects with GC resistance which would allow to use intensified treatment strategies higher dose or alternative immune modulatory therapy to overcome resistance On the other hand strong responsiveness to GC would provide a rational for rapid steroid tapering or treatment with lower doses both resulting in reduced risk for GC related adverse events such as osteoporosis infections diabetes and mood disorders Detailed understanding of the relation of individual GC signaling and GC metabolism with patients response to steroid treatment will help to define steroid responder profiles This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR andor GCA
At inclusion and at all follow-up visits the clinical evaluation will be documented in the SCQM database All participants with PMR will be treated according to our local treatment protocol starting dose is 15 mg prednisoned tapered by 25 mg every second week once symptoms are controlled After tapering to 10 mgd prednisone dose is further reduced by 25 mg every month
All patients with GCA are treated according to published guidelines with prednisone starting at 1mgkg body-weight followed by reduction to 0 mg at week 26 GIACTA protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None