Rheumatoid Arthritis Adrenal Recovery Study

NCT03294876 | Completed

• 1 other identifier: AC17080
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Cortisol is a naturally occurring stress hormone, made by the adrenal glands in response to hormones produced by the pituitary and hypothalamus. Man-made forms of cortisol ('steroids', for example prednisolone) have been used for the treatment of rheumatoid arthritis since the 1950s; they are very effective at reducing inflammation. A normal response to taking steroid treatment is that the body needs to make less cortisol. Following treatment with steroids, the system responsible for making cortisol can be slow to wake up. If someone does not make enough cortisol, they are less able to deal with stress and are at increased risk of becoming unwell, or suffering a potentially fatal adrenal crisis. It is not clear how common failure of recovery of the adrenal axis is, how long it can last for or, if any factors might predict which patients are most at risk. This study aims to improve our understanding of hypothalamus-pituitary-adrenal (HPA) axis recovery in patients with rheumatoid arthritis treated with prednisolone. The investigators will also test potential predictive biomarkers of recovery. The study will be conducted in hospital and a clinical research facility. Participants will undergo two visits for blood tests and will also be asked to supply three samples of saliva on six days over the three weeks of the study. A better understanding of the physiology of HPA axis recovery should inform the development of tools which would allow prediction of patients at risk following withdrawal of steroid treatment. Such tools would be useful to improve patient safety.

Conditions

Rheumatoid Arthritis; Adrenal Insufficiency

Keywords

Glucocorticoid; HPA axis

Outcome Measures

Primary Outcomes (3)

• Synacthen test 1

  Short synacthen test the after withdrawal of prednisone

  Day 1

• Synacthen test 2

  Short synacthen test 21 days after withdrawal of prednisone

  Day 21

• Cortisol awakening curve

  Salivary cortisol at waking, and 30 mins and 45 mins after waking

  2 days in each of weeks 1, 2 and 3

Secondary Outcomes (3)

• Single Nucleotide Polymorphism

  Assessed at day 0

• Quality of life

  Assessed at day 21

• Metabolite panel

  Day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited following 13 week weaning dose of prednisone for treatment of early arthritis

You may qualify if:

• Rheumatoid arthritis
• Treatment with prednisone via COBRA light regime
• Age over 18

You may not qualify if:

• Adrenal or pituitary disease
• Alcohol intake over 21 units/week
• Shift work (night shifts)

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Metabolic Unit, Western General Hospital, NHS Lothian, Crewe Road

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Blood for DNA Saliva

MeSH Terms

Conditions

Arthritis, Rheumatoid; Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Thomas JG Chambers, PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: October 10, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 29, 2020
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)