patients with ulcerative colitis MedDRA version: 20.0 Level: LLT Classification code 10045282 Term: UC System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Pharmaceutical Form: Powder for solution for infusion
INN or Pro
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: ¿ To investigate risk factors associated to a higher risk of relapse after infliximab withdrawal ¿ To investigate the mean time between infliximab withdrawal and clinical relapse. ¿ To assess the safety of the two therapeutic strategies. ¿ 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes will be: - Mean time to relapse in the two groups - Number of adverse events of the two study strategies - Number of serious adverse events of the two study strategies - Impact of predetermined baseline risk factors (see below) for relapse - Direct costs of the two treatment strategies; Sub-study endpoint 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 | — |
Countries
Italy
Contacts
Public Contactn.a.
IRCCS Istituto Clinico Humanitas
Outcome results
None listed