Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark

Tracking Information
First Submitted Date July 28, 2011
First Posted Date August 5, 2011
Last Update Posted Date April 28, 2017
Study Start Date April 2011
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2017)
adrenal insufficiency [ Time Frame: upon first visit within average 1 month ]
test for adrenal function by stimulation test (Synacthen test)
Original Primary Outcome Measures
 (submitted: August 4, 2011)
adrenal insufficiency [ Time Frame: upon first visit within average 1 month ]
test for adrenal function by stimulation test
Change History
Current Secondary Outcome Measures
 (submitted: April 26, 2017)
  • 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
Original Secondary Outcome Measures
 (submitted: August 4, 2011)
quality of life [ Time Frame: upon inclusion (baseline) ]
test by questionnaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Difference in GC-induced Adrenal Insufficiency in RA Related to Polymorphisms in the Glucocorticoid Receptor Gene
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
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, ER22/23EK 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood samples and DNA from gene analyses
Sampling Method Non-Probability Sample
Study Population Consecutive patients with rheumatoid arthritis in prednioslone treatment, screened for four specific polymorphisms of the glucocorticoid receptor gene.
Condition Rheumatoid Arthritis
Intervention 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).
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Synacthen test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 26, 2017)
106
Original Estimated Enrollment
 (submitted: August 4, 2011)
50
Estimated Study Completion Date December 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients > 18 years)
  • Caucasian classified with rheumatoid arthritis.
  • 1987 ACR-classification criteria.
  • Prednisolone min 5mg/day for at least 6 months.
  • Presence of either BclI (high GC sensitivity) or 9β (low GC sensitivity)polymorphisms, or wildtype for for all 4 SNPs studied. Patients with or without these polymorphisms were invited to a Synacthen® test, but patients with a mixed hetero- and homozygote genotype were not

Exclusion Criteria:

  • Other major organ disease
  • Females pregnant
  • Females not willing to pause estrogen-containing medications 6 weeks prior to Synacthen® test
  • unable to give a written informed content
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01411046
Other Study ID Numbers GCR-RA-CSI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Ulla Feldt-Rasmussen, Professor Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date April 2017