An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

Inclusion Criteria

-The subject is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of their randomization in Study MLN0002-2003. (Note: A subject remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.)
-The subject completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of =2 points and =25% from Baseline, or a reduction of the PUCAI of =20 points from baseline for subjects with UC; or a reduction of the CDAI as defined by a =70-point decrease from Baseline or a decrease of PCDAI of =15 points for subjects with CD.
-Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, or other known risk factor must be up-to-date on colorectal cancer surveillance.
-The subject may be receiving a therapeutic dose of the following drugs:
– Oral 5-aminosalicylic (5-ASA) compounds.
– Oral corticosteroid therapy (prednisone or equivalent steroid at a dose =50 mg/day).
– Topical (rectal) treatment with 5-ASA or corticosteroids.
– Probiotics (eg, Saccharomyces boulardii).
– Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
– Antibiotics used for treatment of CD (eg, ciprofloxacin, metronidazole).
– Azathioprine, 6-mercaptopurine, or methotrexate provided the subject was receiving this medication during prior participation in Study MLN0002-2003.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-The subject is female and is lactating or pregnant.
-The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.
-The subject has withdrawn from Study MLN0002-2003.
-The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety.
-The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
-The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
-The subject has other serious comorbidities that will limit their ability to complete the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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