The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (\<) 18 years old in the USA, or 6 through less than (\<) 18 years old in other countries and determine if it is similar to that observed in adults with moderately to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part of the study continues to Week 16, at which point all subjects who are receiving benefit from ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at Week 268 or upon availability of the LTE basket study (CNTO1275ISD3001) whichever occurs first. If participants do not consent/assent to the LTE basket study, they will continue safety follow-up for approximately 20 weeks after the last study agent administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Subjects will receive a single IV administration of ustekinumab (3 mg/kg for subjects \<40 kg or 130 mg for subjects \>= 40 kg in Group 1 and 9 mg/kg for subjects \< 40 kg or 390 mg for subjects \>= 40 kg in group 2) at week 0 followed by SC administration of ustekinumab (2 mg/kg for subjects \< 40 kg or 90 mg for subjects \>= 40 kg at Week 8.
Cedars Sinai Medical Center
Los Angeles, California, United States
Connecticut Childrens Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Children's Center For Digestive Healthcare, Llc
Atlanta, Georgia, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Mount Sinai
New York, New York, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Center For Digestive Health Systems-Greenville
Greenville, South Carolina, United States
Universitair Kinderziekenhuis Koningin Fabiola
Brussels, Belgium
...and 16 more locations
Serum Ustekinumab Concentrations Over Time
Serum samples will be collected to measure seum concentrations of Ustekinumab.
Time frame: Up to Week 16
Clinical Response as Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score
Clinical Response is defined as greater than or equal to (\>=) 15-point reduction from baseline in the total Pediatric Crohn's Disease Activity Index (PCDAI) score, accompanied by a total PDCAI score of less than or equal to (\<=) 30 points. PCDAI is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease.
Time frame: Week 6
Clinical Remission as Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score
Clinical remission is defined as PCDAI score of less than or equal to (\<=) 10. PCDAI is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte, sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease.
Time frame: Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.