Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

Launched by JAROSLAW KIERKUS · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two medications, vedolizumab and infliximab, to see which one is safer and more effective for treating pediatric patients with ulcerative colitis (UC). UC is a condition that causes inflammation in the intestines, leading to symptoms like diarrhea and abdominal pain. The trial is specifically for children and teenagers aged 6 to 17 years who have moderate to severe UC and have not responded well to other treatments. Vedolizumab is a newer drug that hasn't been widely used in children yet, while infliximab is an established treatment.

To participate, children must meet certain criteria, such as having a confirmed diagnosis of UC and having tried other treatments without success. Before joining the study, a parent or guardian will need to give consent, and participants aged 16 and older will also need to provide their own agreement. Throughout the trial, participants will have regular check-ups to monitor their health and any side effects from the medications. This study aims to find the best options for managing UC in young patients and could help improve future treatments for this condition.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Participant aged 6 to 17 years at the time of study entry.
• • 2. Patient with moderate or severe UC defined by the PUCAI score (min. 30 points) - diagnosed at least 1 month before the qualifying visit.
• 3. 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
• • 4. Patients with UC proximal to the rectum (i.e. not limited to proctitis).
• • 5. At least Mayo 1 on the endoscopic scale
• • 6. People with up-to-date vaccinations in accordance with the preventive vaccination program adopted in Poland.
• • Exclusion criteria
• • 1. People who have been previously treated with biological antiintegrin preparations, including: natalizumab, efalizumab, etrolizumab or addressin-1 adhesion molecule antagonists or rituximab.
• • 2. People who were previously treated with vedolizumab.
• • 3. People who were previously treated with infliximab
• • 4. People with hypersensitivity or allergy to any of the excipients of vedolizumab or infliximab
• • 5. 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.
• • 6. Individuals who currently require or are expected to require surgical intervention for UC during this study.
• • 7. People who have had a partial or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal stoma, or known permanent intestinal stricture.
• • 8. People with a current diagnosis of unspecified colitis.
• • 9. People with clinical features suggestive of monogenic inflammatory bowel disease of very early onset.
• • 10. The participant has other serious comorbidities that will limit his or her ability to complete the study.
• 11. 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:
• • 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
• • vital signs, results of standard laboratory tests