Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Curre
Sponsors
Takeda Development Centre Americas, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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. -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
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 -The subject has withdrawn from Study MLN0002-2003.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD. ;Secondary Objective: -To evaluate the efficacy of long-term vedolizumab IV in pediatric subjects with UC or CD. -To determine the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel disease (IBD)-related events (hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD. -To examine the effect of long-term vedolizumab IV treatment on health-related quality-of- life measurements in pediatric subjects with UC or CD. -To determine the effect of long-term vedolizumab IV treatment on patterns of growth and development in pediatric subjects with UC or CD.;Primary end point(s): The primary endpoint for this study is percentage of subjects with treatment-emergent adverse events (TEAEs). ;Timepoint(s) of evaluation of this end point: Monitored throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints for this study are: - Percentage of UC subjects who, at Week 32, achieve and maintain clinical response based on complete Mayo score, as defined by a continued reduction in complete Mayo score of =3 points from the baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of =1 point from baseline, or absolute rectal bleeding subscore of =1 point at Week 32. - Percentage of CD subjects who, at Week 32, achieve and maintain clinical response as defined by a 50% reduction in SES-CD score on endoscopy compared to the baselineendoscopy (at initiation of MLN0002-2003); and continued reduction in CDAI that is a =70 point decrease from the baseline CDAI score at the initiation of MLN0002-2003. - Time to major IBD-related events (hospitalizations, surgeries, or procedures). - Changes from Baseline in IMPACT-III (where translations are available) total and subscale scores at Week 24 and every 24 weeks, thereafter. - Height velocity at Week 48 and every 48 weeks, thereafter. - Change from Baseline in height, weight, and body mass index (BMI) at Week 24 and every 24 weeks, thereafter. - Percentage of subjects achieving Tanner stage V at or before age 16 years (females) or 17 years (males).;Timepoint(s) of evaluation of this end point: Monitored throughout the study | — |
Countries
Belgium, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Ukraine, United Kingdom, United States
Contacts
Public ContactTakeda Study Registration Call Cent
Takeda
Outcome results
None listed