Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

Prior treatment

• People who have been previously treated with biological antiintegrin preparations, including: natalizumab, efalizumab, etrolizumab or addressin-1 adhesion molecule antagonists or rituximab.
• People who were previously treated with vedolizumab.
• People who were previously treated with infliximab
• Individuals who currently require or are expected to require surgical intervention for UC during this study.

Other illness

• People with hypersensitivity or allergy to any of the excipients of vedolizumab or infliximab
• People with active brain/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other serious neurological disorder including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
• People with clinical features suggestive of monogenic inflammatory bowel disease of very early onset.
• occurrence of: adverse events (AEs), serious AEs (serious AEs-SAEs), infections including opportunistic infections such as PML, liver damage, malignant tumors, infusion-related reactions and hypersensitivity

Lab values

• Abnormal laboratory tests:
  • Hgb ≤ 8 g/dl
  • Leukocytes ≤ 2.5 x 10\*9 cells/L
  • ALT and/or AST ≥ 3 x upper limit of normal
  • positive Quantiferon result
  • positive result in the stool sample for Clostridium difficile and/or stool culture for alarm pathogens Security
  • At every check-up visit:
• vital signs, results of standard laboratory tests

Other

• People who have had a partial or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal stoma, or known permanent intestinal stricture.
• People with a current diagnosis of unspecified colitis.
• The participant has other serious comorbidities that will limit his or her ability to complete the study.

• Participant aged 6 to 17 years at the time of study entry.
• Patient with moderate or severe UC defined by the PUCAI score (min. 30 points) - diagnosed at least 1 month before the qualifying visit.
• Individuals who failed to respond to, lost response to, or were intolerant to treatment with at least 1 of the following agents:
  • corticosteroids (prednisone at a dose of 1 mg/kg/day with a maximum dose of 40 mg/day, budesonide MMX 9 mg/day) or immunomodulating drugs (e.g. AZA, 6-MP, MTX).
  • in the case of 5 - ASA adrugs, corticosteroids, immunomodulating drugs, doses should remain stable for 2 weeks before administration of the study drug
• Patients with UC proximal to the rectum (i.e. not limited to proctitis).
• At least Mayo 1 on the endoscopic scale
• People with up-to-date vaccinations in accordance with the preventive vaccination program adopted in Poland.