MLN0002-3029
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease
- Sex at Birth: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Ulcerative Colitis
Study Purpose
This is a follow up study because there was a positive response to the MLN0002-3024 or MLN0002-3025 study, for ulcerative colitis (UC) or Crohn’s disease (CD). UC is a long-term disease that can cause diarrhea and lower abdominal (belly) pain. Standard treatments for UC include medicines, such as steroids, that help to reduce the inflammation (pain and swelling) of your intestines (guts) or change your immune system (the body’s natural defenses). This is a new study that tests the long-term safety of vedolizumab for patients who started treatment between ages 2 and 17 and also participated in Study MLN0002-3024 (subjects with UC) or MLN0002-3025 (subjects with CD). CD is a long-term disease that can cause diarrhea, abdominal pain, fever, loss of appetite, weight loss, poor nourishment, and rectal bleeding (which may be persistent and lead to anemia [not enough iron in blood]). Standard treatments for CD include medicines, such as steroids, that help to reduce the inflammation of your intestines or change your immune system (the body’s natural defenses).
Locations
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: SITE00002079
- StudyID: 2022-01047
- ClinicalTrials.gov: N/A
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