An observational study in Rheumatoid Arthritis and Adrenal Insufficiency, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Edinburgh · Observational
Among 314 studies in Arthritis, Rheumatoid with a site in United Kingdom — 18 open to participants now, 40 under way, 3 of them phase 3. Arthritis, Rheumatoid · United Kingdom.
Among the 314 studies in Arthritis, Rheumatoid with a site in United Kingdom, this one is the 74th largest by enrollment of the 75 observational ones that give a count, is one of 5 that started in 2018, is one of 75 observational ones, and was the 240th registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
Browse Arthritis, Rheumatoid studies →18 of the 314 studies in Arthritis, Rheumatoid with a site in United Kingdom are open now. Recruiting first, the newest first:
University of Ulster · Sites in United Kingdom
Quell Therapeutics Limited · Sites in United Kingdom, Germany, Spain
AstraZeneca · Sites in United Kingdom, United States, Australia and 3 more countries
AstraZeneca · Sites in United Kingdom, United States, Argentina and 14 more countries
Hoffmann-La Roche · Sites in United Kingdom, United States, Argentina and 9 more countries
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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314 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 34 · Phase 2 69 · Phase 3 81 · Phase 4 37
First in 1995; this study’s year is marked. 5 started in 2018.
This study's enrollment of 7 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 210 across the 239 interventional studies, 151 across the 75 observational. Of the 257 that completed or were terminated, 137 (53%) have results posted.
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244 of 314 have an industry lead sponsor. The 10 most frequent:
University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
University of Edinburgh has 1 study filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
9 of the studies in Arthritis, Rheumatoid with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01480440Zimmer BiometOutcomes Study of the Trabecular Metal (TM) Reverse Shoulder System | 2026-12 |
| NCT02337244Zimmer, GmbHZimmer POLAR Persona - TKA (EMEA Study) | 2026-12 |
| NCT06240299NHS Greater Glasgow and ClydeNeurofeedback for Nociplastic Pain in Rheumatoid Arthritis (NECTAR) | 2027-01-29 |
| NCT07137598Hoffmann-La RocheA Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors) | 2027-04-17 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
Among the 314 studies in Arthritis, Rheumatoid with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Cortisol is a naturally occurring stress hormone. It is 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. Steroids are prescribed for a wide variety of inflammatory conditions. The British prevalence of chronic (greater than 3 months) steroid prescription is 1%.
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 (known as the hypothalamic pituitary adrenal axis (HPA axis)) can be slow to re-establish production. 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. The prevalence of inadequate cortisol production following treatment with steroids is between 10-30% of patients; its duration and whether any patient factors might predict which patients are at risk is unclear. Generally studies have been small in size and do not report sufficient information to determine if any potential factors maybe useful predictors; for example age, sex, length of treatment, length of time off treatment, other medications.
Rheumatoid arthritis (RA) has a prevalence of 1%. Patients are usually treated with a 13 week course of prednisolone in a reducing dose (treatment regimen known as COBRA-light) at diagnosis. 1-2 patients present each week to the rheumatology department in Edinburgh with a new diagnosis of RA. At the end of the initial COBRA-light treatment, the adrenal axis is not routinely assessed in these patients. It is assumed that the slow reducing dosage of steroids reduces the risk of ongoing adrenal insufficiency. It should be noted that the meta-analysis of Joseph et al. demonstrated weaning had little impact upon the recovery of the HPA axis. These patients are thus potentially at risk of the morbidity and mortality associated with an underactive HPA axis.
This study aims to improve our understanding of HPA axis recovery in patients with rheumatoid arthritis following treatment with prednisolone. The investigators will also test two novel potential predictive biomarkers of recovery.
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 and wellbeing.
Patients recruited following 13 week weaning dose of prednisone for treatment of early arthritis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Synacthen test 1
Short synacthen test the after withdrawal of prednisone
Time frame: Day 1
Synacthen test 2
Short synacthen test 21 days after withdrawal of prednisone
Time frame: Day 21
Cortisol awakening curve
Salivary cortisol at waking, and 30 mins and 45 mins after waking
Time frame: 2 days in each of weeks 1, 2 and 3
Single Nucleotide Polymorphism
Assessment of an SNP as a predictor of prolonged HPA axis suppression
Time frame: Assessed at day 0
Quality of life
SF-36 (Short Form Survey) assessed quality of life
Time frame: Assessed at day 21
Metabolite panel
Assessment of a panel of metabolites which might predict HPA suppression
Time frame: Day 0
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Dec 2019, 14 months.
Of 234 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 145. This study's 14 months is below that.
Counting every sponsor, half of 389 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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