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Difference in GC-induced Adrenal Insufficiency in RA Related to Polymorphisms in the Glucocorticoid Receptor Gene

This study is currently recruiting participants.
Verified March 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01411046
First received: July 28, 2011
Last updated: March 10, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
 Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • adrenal insufficiency [ Time Frame: upon first visit within average 1 month ] [ Designated as safety issue: Yes ]
    test for adrenal function by stimulation test


Secondary Outcome Measures:
  • quality of life [ Time Frame: upon inclusion (baseline) ] [ Designated as safety issue: No ]
    test by questionnaires


Biospecimen Retention:   Samples With DNA

blood samples and DNA from gene analyses


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RA treated with glucocorticoid
50 pts with RA
 Other: No intervention
No intervention

Detailed Description:

Blood is sampled from 200 pts with rheumatoid arthritis (RA), fulfilling the inclusion criteria and their GR haplotypes will be determined by polymerase chain reaction (PCR). 2 x 25 patients with the interesting GR polymorphisms, and these will be included for a Synacthen test of 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

50 consecutive patients with rheumatoid arthritis

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.

Exclusion Criteria:

  • Other major organ disease
  • Endocrine disease
  • Active infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411046

Contacts
Contact: Ulla Feldt-Rasmussen, Professor +45 35451023 ufeldt@rh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Ulla Feldt-Rasmussen, Professor     +4535451023     ulla.feldt-rasmussen@dadlnet.dk    
Principal Investigator: Ulla Feldt-Rasmussen, Professor            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Ulla Feldt-Rasmussen, Professor Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Ulla Feldt-Rasmussen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01411046     History of Changes
Other Study ID Numbers: GCR-RA-CSI
Study First Received: July 28, 2011
Last Updated: March 10, 2013
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by Rigshospitalet, Denmark:
Glucocorticoid
polymorphism
Glucocorticoid receptor gene
 rheumatoid arthritis
adrenal insufficiency
prednisolone treatment

Additional relevant MeSH terms:
Adrenal Insufficiency
Addison Disease
Arthritis
Arthritis, Rheumatoid
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013