A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Main Criteria for Inclusion in the Treatment Cohort:
1. In the opinion of the investigator, the subject, parent, or legal guardian is capable of understanding and complying with protocol requirements.
2. The subject, parent, or legal guardian signs and dates a written, informed consent form and any required privacy authorization before the initiation of any study procedures.
3. The subject is male or female with UC or CD and aged <18 years. (Note: Subjects who reach adult age [18 years of age in most jurisdictions/regions] during the study should be considered to transition to commercial drug if available in their country, especially if transition to an adult care setting is required by local regulation.).
4. The subject has completed Study MLN0002-3024 or Study MLN0002-3025 and has achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of =2 points and =25% from baseline for subjects with UC; or a reduction of PCDAI of =15 points for subjects with CD from baseline of the parent study.
5. A male subject who is sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (eg, condom with or without spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception.
6. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and 18 weeks after the last dose.

Main Criteria for Inclusion in the Observational Cohort:
7. The subject, parent, or legal guardian signs and dates a written, informed consent form.
8. The subject has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 240
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

Treatment Cohort only:
1. The subject is female an
1. The subject is female and is lactating or pregnant.
2. The subject has hypersensitivity or allergies to vedolizumab and any of its excipients.
3. 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.
4. 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.
5. The subject has other serious comorbidities that will limit their ability to complete the study.
6. The subject is unable to comply with all study assessments.

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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