Colitis, Ulcerative Clinical Trial
Official title:
Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab
Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least
12 months of treatment will be randomized to continue IFX or to stop IFX and start
Azathioprine (AZA).
Each patient will be followed for 12 months.
All eligible subjects will be able to participate in the study at any infusion occurred
after 12 months since the beginning. They will be screened by medical history, physical
examination, blood and faecal tests (included C-reactive protein and faecal calprotectin),
as required by clinical practice. No children, pregnant or breastfeeding women, or elder
subjects will be included. A colonoscopy + biopsies in the area of greater inflammation will
be performed within ± 3 weeks since the baseline visit. The subjects can then be randomized
and receive their first dose of study medication.
Subjects will be then evaluated every 8 weeks for the following 12 months from the
randomization. Clinical and blood tests will be performed, and the partial Mayo Score will
be calculated at each visit, until the final visit, when a new colonoscopy with biopsies
will be repeated and the global Mayo Score will be evaluated. At final visit a new faecal
sample for calprotectin will be collected.
Safety of the study treatments will be evaluated at each study visit. In case of study agent
discontinuation, the patient will be managed according to usual practice and followed for
the entire study period. Patients randomized in AZA arm, could restart IFX.
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