Difference in GC-induced Adrenal Insufficiency in RA Related to Polymorphisms in the Glucocorticoid Receptor Gene
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01411046|
Recruitment Status : Unknown
Verified April 2017 by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : August 5, 2011
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Diagnostic Test: Synacthen test|
|Study Type :||Observational|
|Estimated Enrollment :||106 participants|
|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|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
RA treated with prednisolone
Patients with RA treated with prednisolone, minimum 5 mg/day for minimum 6 months. Patients are grouped according to haplotype of 4 SNPs of the glucocorticoid recepror gene. Patients with or without these polymorphisms were invited to a Synacthen® test, but patients with a mixed hetero- and homozygote genotype were not. Adrenal function is evaluated with a Synacthen test.
Diagnostic Test: Synacthen test
250 microg Synacthen test, performed fasting, in the morning, starting between 08·00 and 10·30 h, after an overnight fast and a prednisolone pause of approximately 48 hours (depending on normal dose administration time).
- adrenal insufficiency [ Time Frame: upon first visit within average 1 month ]test for adrenal function by stimulation test (Synacthen test)
- quality of life [ Time Frame: upon inclusion (baseline) ]test by questionnaires
- Bone Density status [ Time Frame: results from latest DXA scan performed in routine settings, bonemarkers upon inclusion (baseline) ]DXA and bone markers
- body composition [ Time Frame: upon inclusion (baselline) ]BMI, waist-, hip- circumferencia
- metabolic syndrome [ Time Frame: upon inclusion (baseline) ]blood lipids, abdominal obesity, blood pressure, fasting plasma glucose
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411046
|Contact: Ulla Feldt-Rasmussen, Professor||+45 firstname.lastname@example.org|
|Copenhagen, Denmark, 2100|
|Contact: Ulla Feldt-Rasmussen, Professor +4535451023 email@example.com|
|Principal Investigator: Ulla Feldt-Rasmussen, Professor|
|Principal Investigator:||Ulla Feldt-Rasmussen, Professor||Rigshospitalet, Denmark|