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RecruitingNCT07866326Updated Oct 8, 2026

Prevalence of Adrenal Insufficiency and Associated Factors in Rheumatoid Arthritis Patients Using Low-dose Corticosteroids.

An observational study in Reumatoid Arthritis, Corticosteroids Adverse Reaction and Adrenal Insufficiency, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 2 months later.
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Reumatoid Arthritis
  • Corticosteroids Adverse Reaction
  • Adrenal Insufficiency

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Keywords

  • Reumatoid Arthritis
  • Adrenal Insufficiency
  • low dose corticosteroid
03

In context

Adrenal Insufficiency

133 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.

This study's planned enrollment of 120 is above the median of 76 across 57 observational studies indexed under Adrenal Insufficiency.

Browse Adrenal Insufficiency studies →

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 46 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population will be selected from RA patients followed at the Rheumatology Clinic of Bursa Yuksek Ihtisas Training and Research Hospital.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 3 week-3 months

    low-duration corticosteroid

    Diagnostic Test: ACTH stimulation test · Diagnostic Test: Cortisol

  • 3-12 months

    medium-duration corticosteroid

    Diagnostic Test: ACTH stimulation test · Diagnostic Test: Cortisol

  • >12 months

    long-duration corticosteroid

    Diagnostic Test: ACTH stimulation test · Diagnostic Test: Cortisol

Interventions

  • Diagnostic testACTH stimulation test

    ACTH stimulation test with 250 micrograms tetracosactide acetate if plasma cortisole is below 10 mcg/dl

  • Diagnostic testCortisol

    morning fasting plasma cortisol

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

  2. DAS-28

    Disease activity score for rheumatoid arthritis

    Time frame: through study completion, an average of 1 year

  3. HAQ

    Health Assessment Questionnaires

    Time frame: through study completion, an average of 1 year

  4. RAPİD-3

    Routine Assessment of Patient Index Data 3

    Time frame: through study completion, an average of 1 year

  5. PASI

    Psoriasis Area Severity Index

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • SBU Bursa Yüksek İhtisas EAH
    Bursa, Yıldırım, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07866326
Lead sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Responsible party
Koray Ayar (Associate Proffessor, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Oct 8, 2026
Start date
Jul 31, 2026
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Koray Ayar, Associated Proffessor (Dr.)
Contact
ayarkoray@hotmail.com
90 224 2955000 ext. 1648

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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