NCT05435547 Preoperative Corticosteroids in Autoimmune Thyroid Disease
| NCT ID | NCT05435547 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Condition | Graves Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2023-06-16 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 76 participants in total. It began in 2023-06-16 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.
Eligibility Criteria
* Inclusion Criteria: ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease. * Exclusion Criteria: * Pediatric patients \< 18 * Prior treatment with RAI * Prior neck surgeries * Known diagnosis of thyroid cancer * Diabetic patients on medications * A history of adverse reactions to corticosteroids. * Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.
Contact & Investigator
Alexandria McDow, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05435547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Graves Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05435547 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05435547 currently recruiting?
Yes, NCT05435547 is actively recruiting participants. Contact the research team at amcdow@iu.edu for enrollment information.
Where is the NCT05435547 trial being conducted?
This trial is being conducted at Indianapolis, United States, Indianapolis, United States, Indianapolis, United States.
Who is sponsoring the NCT05435547 clinical trial?
NCT05435547 is sponsored by Indiana University. The principal investigator is Alexandria McDow, MD at Indiana University. The trial plans to enroll 76 participants.