Search / Trial NCT06614387

Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

Launched by JAROSLAW KIERKUS · Sep 25, 2024

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Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Ulcerative Colitis Vedolizumab Infliximab Children

Description

No description provided

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

About Jaroslaw Kierkus

Jaroslaw Kierkus is a distinguished clinical trial sponsor renowned for his commitment to advancing medical research and innovation. With a robust background in clinical pharmacology and a focus on the development of novel therapeutic interventions, he leads initiatives that prioritize patient safety and ethical standards. His collaborative approach fosters partnerships with leading research institutions and healthcare professionals, ensuring rigorous trial design and execution. Under his guidance, the organization aims to contribute significantly to the global medical community by delivering evidence-based solutions that enhance patient outcomes and improve healthcare practices.

Locations

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Timeline

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Trial launched

Trial updated

Estimated completion

Not reported

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