drugset / Trial / NCT07248644
Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission
Phase 4
Not yet recruiting
304 enrolled
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
RandomizedParallel-groupOpen-labelTreatment
Summary
IDEA is a Phase IV, prospective, randomised, open-label, multicentre clinical trial designed to evaluate the safety and efficacy of withdrawing thiopurines in elderly (≥60 years) patients with ulcerative colitis (UC) who are in sustained clinical and biological remission. The study compares discontinuation of thiopurines versus continuation while maintaining background mesalamine therapy over 24 months of treatment.
Timeline
- Start
- 2026-05-01
- Primary completion
- 2026-09
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | — | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Subject | Mesalamine | Small molecule | 4 g | Oral |