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Immunosuppressant Discontinuation in Elderly patients with ulcerative colitis And long-term remission
EU CTIS ID: 2025-524675-23-00
What this study is testing
To evaluate the biological recurrence rate at 24 months of follow-up after discontinuation of thiopurines in patients with quiescent Ulcerative Colitis in prolonged remission and advanced age compared to those who continue treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age 60 years or older.
- 2. Established diagnosis of ulcerative colitis according to ECCO criteria.
- 3. Treatment with azathioprine (AZA; 1–2.5 mg/kg/day) or mercaptopurine (MP; 0.75–1.5 mg/kg/day) for ≥5 consecutive years, at stable doses (minimum effective dose without adverse effects) during the last 12 months.
- 4. In the case of concomitant treatment with oral mesalazine, stable doses for the last 12 months.
- 5. Clinical remission maintained for ≥3 years, in the investigator's opinion, defined as: i. Absence of flare-ups requiring systemic corticosteroids (oral or IV) or biological agents. ii. The use of stable oral mesalazine and/or topical rectal treatments is permitted if the dose has remained stable over the last 12 months.
- 6. Objective clinical remission at the inclusion visit: (1) Partial Mayo index ≤2 (with rectal bleeding subindex equal to 0).
You likely can't join if
- 1. Ulcerative proctitis (maximum extent observed <25 cm during the course of the disease).
- 10. Neutrophil count <1500x10⁶ cells/mm³, lymphocytes <500x10⁶ cells/mm³, platelets <120,000x10⁶ cells/mm³, haemoglobin <12 g/dL (women) or 13 g/dL (men) at the time of inclusion.
- 2. Total or segmental colectomy
- 3. Ileoanal reservoir
- 4. History of complex perianal disease
- 5. Intolerance to oral 5-ASA
See the full eligibility criteria
- 1. Age 60 years or older.
- 2. Established diagnosis of ulcerative colitis according to ECCO criteria.
- 3. Treatment with azathioprine (AZA; 1–2.5 mg/kg/day) or mercaptopurine (MP; 0.75–1.5 mg/kg/day) for ≥5 consecutive years, at stable doses (minimum effective dose without adverse effects) during the last 12 months.
- 4. In the case of concomitant treatment with oral mesalazine, stable doses for the last 12 months.
- 5. Clinical remission maintained for ≥3 years, in the investigator's opinion, defined as: i. Absence of flare-ups requiring systemic corticosteroids (oral or IV) or biological agents. ii. The use of stable oral mesalazine and/or topical rectal treatments is permitted if the dose has remained stable over the last 12 months.
- 6. Objective clinical remission at the inclusion visit: (1) Partial Mayo index ≤2 (with rectal bleeding subindex equal to 0).
- 7. Endoscopic remission confirmed by colonoscopy performed within 12 months prior to study inclusion with endoscopic Mayo subindex=0 according to clinical practice.
- 8. Subclinical inflammatory remission: Baseline faecal calprotectin ≤150 mg/kg, measured approximately 1 month (+/- 1 week) prior to randomisation.
- 9. Written informed consent.
- 1. Ulcerative proctitis (maximum extent observed <25 cm during the course of the disease).
- 10. Neutrophil count <1500x10⁶ cells/mm³, lymphocytes <500x10⁶ cells/mm³, platelets <120,000x10⁶ cells/mm³, haemoglobin <12 g/dL (women) or 13 g/dL (men) at the time of inclusion.
- 2. Total or segmental colectomy
- 3. Ileoanal reservoir
- 4. History of complex perianal disease
- 5. Intolerance to oral 5-ASA
- 6. Current or previous treatment with any selective immunomodulator or advanced therapy approved for the treatment of ulcerative colitis for any indication.
- 7. Cessation of topical treatment (mesalazine or steroids) in the 3 months prior to inclusion
- 8. CRF with creatinine ≥2mg/dl (glomerular filtration rate ≤ 30mL/min/1.73m2)
- 9. Abnormal liver function tests (AST, ALT, alkaline phosphatase or GGT elevated >2 times the upper limit of normal) at the time of inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.