Reumatoid ArthritisNCT07866326
Prevalence of Adrenal Insufficiency and Associated Factors in Rheumatoid Arthritis Patients Using Low-dose Corticosteroids.
An observational study of Reumatoid Arthritis and Corticosteroids Adverse Reaction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the prevalence of adrenal insufficiency in rheumatoid arthritis (RA) patients receiving low-dose corticosteroid therapy and to identify the factors influencing adrenal insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reumatoid Arthritis, Corticosteroids Adverse Reaction, Adrenal Insufficiency
- What is being tested?
- ACTH stimulation test and Cortisol
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2026to 30 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be selected from RA patients followed at the Rheumatology Clinic of Bursa Yuksek Ihtisas Training and Research Hospital.
Who may be able to join
- Participants diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR criteria.
- Participants who have been undergoing corticosteroid treatment for at least 3 weeks.
- Participants in remission or with low disease activity (DAS28-CRP ≤3.2).
Who cannot join
- Patients with primary adrenal insufficiency.
- Participants who have received pulse steroid therapy within the last 6 months.
- Pregnancy and lactation.
- Hypopituitarism
- Uncontrolled diabetes mellitus
- Comorbidities; ≥NYHA Class 3 heart failure, Stage 3 chronic kidney failure, ≥Child-Pugh Class B liver cirrhosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBU Bursa Yüksek İhtisas EAH
Bursa, Yıldırım
Sabiha Kömoğlu, Dr., +90 5065990764, sabihakomoglu@gmail.com
About this study
Official title: Prevalence of Adrenal Insufficiency and Influencing Factors in Patients With Rheumatoid Arthritis and Using Low-dose Corticosteroids.
This study aims to investigate the prevalence of adrenal insufficiency in rheumatoid arthritis (RA) patients receiving low-dose corticosteroid therapy and to identify the factors influencing adrenal insufficiency. To this end, the researchers plan to conduct a study comparing the prevalence of adrenal insufficiency and associated factors among RA patients-who are currently receiving low-dose corticosteroid therapy during outpatient follow-up and have consented to participate-by categorizing them into three groups based on the duration of treatment: short (3 weeks-3 months), medium (3-12 months), and long (>12 months).
Read the detailed description
Although corticosteroids are used as "bridge therapy" in the treatment of rheumatoid arthritis (RA), many patients continue on low-dose corticosteroid regimens. Prolonged high-dose corticosteroid therapy can lead to permanent adrenal insufficiency, a fact well-documented in the literature. The human body produces the equivalent of 5-7.5 mg of prednisolone daily; however, data regarding the frequency of adrenal insufficiency associated with the use of therapeutic corticosteroid doses below this endogenous production level are limited. This study aims to investigate the presence of adrenal insufficiency-in accordance with guideline recommendations-among rheumatoid arthritis patients undergoing low-dose corticosteroid therapy (defined as doses not exceeding the equivalent of 5 mg of prednisolone) for short (3 weeks to 3 months), medium (3 to 12 months), and long (more than 12 months) durations. This study also aims to investigate the factors contributing to the development of adrenal insufficiency in rheumatoid arthritis (RA) patients receiving short-, medium-, and long-term corticosteroid therapy.
- Being tested
- ACTH stimulation test, Cortisol
- Keywords
- Reumatoid Arthritis, Adrenal Insufficiency, low dose corticosteroid
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTH stimulation testDiagnostic test
ACTH stimulation test with 250 micrograms tetracosactide acetate if plasma cortisole is below 10 mcg/dl
CortisolDiagnostic test
morning fasting plasma cortisol
| Study group | Role | What they receive |
|---|---|---|
| 3 week-3 months | low-duration corticosteroid Receives: Diagnostic Test: ACTH stimulation test; Diagnostic Test: Cortisol | |
| 3-12 months | medium-duration corticosteroid Receives: Diagnostic Test: ACTH stimulation test; Diagnostic Test: Cortisol | |
| >12 months | long-duration corticosteroid Receives: Diagnostic Test: ACTH stimulation test; Diagnostic Test: Cortisol |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of adrenal insufficiency
The assessment of adrenal insufficiency is conducted in two stages: the morning cortisol level is measured in the first stage, and the ACTH stimulation test is administered to the relevant participants in the second stage.
Measured: through study completion, an average of 1 year
DAS-28
Disease activity score for rheumatoid arthritis
Measured: through study completion, an average of 1 year
HAQ
Health Assessment Questionnaires
Measured: through study completion, an average of 1 year
RAPİD-3
Routine Assessment of Patient Index Data 3
Measured: through study completion, an average of 1 year
PASI
Psoriasis Area Severity Index
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start31 Jul 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Koray Ayar, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866326
- Sponsor's protocol ID
- 2024-TBEK 2026-07/01
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Adrenal Insufficiency and Influencing Factors in Patients With Rheumatoid Arthritis and Using Low-dose Corticosteroids.
- ClinicalTrials.gov ID
- NCT07866326
- Acronym / sponsor ID
- 2024-TBEK 2026-07/01
- Keywords
- Reumatoid Arthritis, Adrenal Insufficiency, low dose corticosteroid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the prevalence of adrenal insufficiency in rheumatoid arthritis (RA) patients receiving low-dose corticosteroid therapy and to identify the factors influencing adrenal insufficiency. To this end, the researchers plan to conduct a study comparing the prevalence of adrenal insufficiency and associated factors among RA patients-who are currently receiving low-dose corticosteroid therapy during outpatient follow-up and have consented to participate-by categorizing them into three groups based on the duration of treatment: short (3 weeks-3 months), medium (3-12 months), and long (>12 months).
Detailed description
Although corticosteroids are used as "bridge therapy" in the treatment of rheumatoid arthritis (RA), many patients continue on low-dose corticosteroid regimens. Prolonged high-dose corticosteroid therapy can lead to permanent adrenal insufficiency, a fact well-documented in the literature. The human body produces the equivalent of 5-7.5 mg of prednisolone daily; however, data regarding the frequency of adrenal insufficiency associated with the use of therapeutic corticosteroid doses below this endogenous production level are limited. This study aims to investigate the presence of adrenal insufficiency-in accordance with guideline recommendations-among rheumatoid arthritis patients undergoing low-dose corticosteroid therapy (defined as doses not exceeding the equivalent of 5 mg of prednisolone) for short (3 weeks to 3 months), medium (3 to 12 months), and long (more than 12 months) durations. This study also aims to investigate the factors contributing to the development of adrenal insufficiency in rheumatoid arthritis (RA) patients receiving short-, medium-, and long-term corticosteroid therapy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 week-3 months | – | Diagnostic Test: ACTH stimulation test, Diagnostic Test: Cortisollow-duration corticosteroid |
| 3-12 months | – | Diagnostic Test: ACTH stimulation test, Diagnostic Test: Cortisolmedium-duration corticosteroid |
| >12 months | – | Diagnostic Test: ACTH stimulation test, Diagnostic Test: Cortisollong-duration corticosteroid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from RA patients followed at the Rheumatology Clinic of Bursa Yuksek Ihtisas Training and Research Hospital.
Key inclusion criteria (3 listed)
- Participants diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR criteria.
- Participants who have been undergoing corticosteroid treatment for at least 3 weeks.
- Participants in remission or with low disease activity (DAS28-CRP ≤3.2).
Key exclusion criteria (6 listed)
- Patients with primary adrenal insufficiency.
- Participants who have received pulse steroid therapy within the last 6 months.
- Pregnancy and lactation.
- Hypopituitarism
- Uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTH stimulation testACTH stimulation test with 250 micrograms tetracosactide acetate if plasma cortisole is below 10 mcg/dl | Diagnostic test | 3 week-3 months, 3-12 months, >12 months |
| Cortisolmorning fasting plasma cortisol | Diagnostic test | 3 week-3 months, 3-12 months, >12 months |
Primary outcome
prevalence of adrenal insufficiency
Time frame: through study completion, an average of 1 year
The assessment of adrenal insufficiency is conducted in two stages: the morning cortisol level is measured in the first stage, and the ACTH stimulation test is administered to the relevant participants in the second stage.
DAS-28
Time frame: through study completion, an average of 1 year
Disease activity score for rheumatoid arthritis
HAQ
Time frame: through study completion, an average of 1 year
Health Assessment Questionnaires
RAPİD-3
Time frame: through study completion, an average of 1 year
Routine Assessment of Patient Index Data 3
PASI
Time frame: through study completion, an average of 1 year
Psoriasis Area Severity Index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reumatoid Arthritis and Corticosteroids Adverse Reaction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koray Ayar, Associated Proffessor (Dr.) (90 224 2955000 ext. 1648, ayarkoray@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of adrenal insufficiency (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.