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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients with primary adrenal insufficiency.

Participants who have received pulse steroid therapy within the last 6 months.

Pregnancy and lactation.

Hypopituitarism

Trial population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • ACTH stimulation test

    Diagnostic test

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

  • Cortisol

    Diagnostic test

    morning fasting plasma cortisol

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: 3 week-3 months2 interventions
Group B: 3-12 months2 interventions
Group C: >12 months2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bursa Yuksek Ihtisas Training and Research Hospital

Lead sponsor

Saglik Bilimleri Universitesi

Sponsor institution