.a.

Phase 1

• Conditions: patients with ulcerative colitis; MedDRA version: 20.0Level: LLTClassification code 10045282Term: UCSystem Organ Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-002707-25-IT
• Lead Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-13
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Age 18 -65 years
- Written informed consent and willing to adhere to study procedures.
- Therapy with infliximab since at least 12 months, with one infusion every 8 weeks (, according to the summary of product characteristics)
- Sustained steroid-free remission in the last 6 months prior to inclusion, except for use of steroids as a preventive measure for infliximab infusion reaction, if required by local guidelines.
- Global Mayo score at baseline = 2
- All Mayo subscores = 1
- Absence of rectal bleeding
- Effective methods to avoid pregnancy during the study period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Disabling and persisting extraintestinal manifestation at baseline
- Patients unable to comply with study procedures
- Known intolerance or previous allergic reaction to
thiopurines
- Concomitant therapy with allopurinol
- Any disease not compatible with the use of infliximab or azathioprine, as per clinician’s judgement.
- Need for dose escalation of infliximab in the last 12
months prior to baseline.
- White blood cell count < 3000/mmc or absolute clinically relevant lymphopenia at baseline
- Active pregnancy or breastfeeding, willing for pregnancy during the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the study is to evaluate whether the withdrawal of infliximab is associated with higher relapse rates compared to controls.;Secondary Objective: Secondary objectives are:<br>¿ To investigate risk factors associated to a higher risk of relapse after infliximab withdrawal<br>¿ To investigate the mean time between infliximab withdrawal and clinical relapse.<br>¿ To assess the safety of the two therapeutic strategies.<br>¿ To evaluate the direct costs of the two different strategies;Primary end point(s): The primary outcome will be the relapse rate by month 12 in the two study groups.;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcomes will be:<br>- Mean time to relapse in the two groups<br>- Number of adverse events of the two study strategies<br>- Number of serious adverse events of the two study<br>strategies<br>- Impact of predetermined baseline risk factors (see below) for relapse<br>- Direct costs of the two treatment strategies; Sub-study endpoint<br>Predictive value of low TL and high ADA at baseline for relapse through week 52;Timepoint(s) of evaluation of this end point: 12 months; baseline and week 52