Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01411046
Status:
UNKNOWN
Last Update Posted:
2017-04-28
First Post:
2011-07-28
Brief Title:
Difference in GC-induced Adrenal Insufficiency in RA Related to Polymorphisms in the Glucocorticoid Receptor Gene
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Observational Cohort Study on Difference in Glucocorticoid-induced Adrenal Insufficiency in Patients With Rheumatoid Arthritis Related to Different Sensitivity Polymorphisms in the Glucocorticoid Receptor Gene
Status:
UNKNOWN
Status Verified Date:
2017-04
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:
Development of glucocorticoid GC-induced adrenal insufficiency is a serious adverse effect of GC treatment It is today not possible to predict this adverse effect The project aims at investigating a possible individual aspect which may render subjects more or less sensitive to glucocorticoids and thereby influence development of GC induced adrenal insufficiency The hypothesis is that subjects with one or another of the polymorphisms in the GC receptor gene will either have increased or diminished GC sensitivity This may be responsible for differences in development of GC induced adrenal insufficiency
Detailed Description:
Blood is sampled from patients with rheumatoid arthritis RA fulfilling the inclusion criteria and patients are genotyped for the SNPs N363S BclI ER2223EK and 9β and grouped according to haplotypes SNPs will be determined by polymerase chain reaction PCR Patients will be included for a Synacthen test to evaluate their adrenal function Information from the results of the study will be able to assist clinicians to identify patients at risk and thus individualize GC therapy in a tailored fashion Results of the study will be important for all patient groups worldwide on GC therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None