Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission

NCT07248644 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IDEA
• Study Type: interventional
• Target: 304
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ulcerative Colitis (UC)

Keywords

thiopurines; 5-ASA; mesalazine

Outcome Measures

Primary Outcomes (1)

• Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation

  To compare the biological-relapse rate at 24 months in elderly patients with quiescent ulcerative colitis (UC) in long-term remission who discontinue thiopurines versus those who continue thiopurine therapy.

  From enrollment to the end of treatment suspension at 24 months.

Study Arms (2)

Discontinuation Arm

EXPERIMENTAL

Immediate cessation of thiopurine therapy while continuing standard mesalamine

Drug: Discontinuation of thiopurines.

Continuation Arm

NO INTERVENTION

Maintenance of current thiopurine dose together with mesalamine.

Interventions

Discontinuation of thiopurines. DRUG

Because thiopurine-related toxicity rises with age while late-onset UC tends to be less aggressive, replacing thiopurines with high-dose oral mesalazine (≥ 3 g/day) may preserve remission and simultaneously reduce long-term oncological and infectious risks.

Also known as: Azathioprine, 6-mercaptopurine

Discontinuation Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥60 years at screening.
• Established diagnosis of ulcerative colitis according to ECCO criteria.
• Clinical and endoscopic remission ≥12 months (Mayo score ≤2, subscore ≤1) according to clinical practice.
• Treatment with a thiopurine (azathioprine 1-2.5 mg/kg/day or mercaptopurine 0.75-1.5 mg/kg/day) for ≥60 months. Treatment at stable doses (minimum effective dose without adverse events in the last 12 months.
• In case of concomitant treatment with oral mesalazine, the dose must´ve been stable for ≥12 months.
• Clinical remission (at the discretion of the investigator) for at least 3 years, without the need for treatment with oral or intravenous steroids or biological agents (topical rectal treatments are permitted as well as oral mesalazine if the dose has remained stable over the past 12 months).
• Colonoscopy performed within 6 months prior to the start of the study in endoscopic remission (Mayo endoscopic index 0) according to clinical practice.
• Two consecutive (centralised determinations in the period of one month) basal faecal calprotectin values \<150 mg/kg during screening.
• Written informed consent.

You may not qualify if:

• Ulcerative proctitis (maximum observed extension \<25 cm throughout the course of the disease)
• History of colectomy or imminent need for surgery.
• Presence of ileoanal reservoir
• History of complex perianal disease
• Intolerance to oral 5-ASA treatment
• Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition.
• Severe chronic renal insufficiency, defined as serum creatinine ≥ 2 mg/dL (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m²).
• Abnormal hepatic laboratory parameters, defined as AST, ALT, alkaline phosphatase, or GGT \> 2X the upper limit of normal (ULN) at screening.
• Hematologic abnormalities at screening, defined as any of the following: absolute neutrophil count \< 1,500 cells/mm³, lymphocytes \< 500 cells/mm³, platelets \< 120,000 cells/mm³, or haemoglobin \< 12 g/dL (females) / \< 13 g/dL (males).
• Any condition that in the investigator's opinion may compromise study participation.

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Azathioprine; Mercaptopurine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds

Study Officials

• Margalida Calafat, MD, PhD

  Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Araya, PhD

CONTACT

+34 674682070; secretariacientifica3@geteccu.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04