The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
159
Ustekinumab will be administered as a SC injection.
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 6 years and 4 months
Number of Participants With Serious Adverse Events (SAEs)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to 6 years and 4 months
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Time frame: Up to 6 years and 4 months
Number of Participants with AEs of Interest
Number of participants with AEs of special interest (any newly identified malignancy case of active tuberculosis \[TB\], or opportunistic infection occurring after the first administration of study intervention\[s\]) will be reported.
Time frame: Up to 6 years and 4 months
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.
Time frame: Up to 6 years and 4 months
Number of Participants with Injection-site Reactions
Number of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
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Children's Center For Digestive Healthcare, Llc
Atlanta, Georgia, United States
Mount Sinai
New York, New York, United States
Levine Childrens at Atrium Health
Charlotte, North Carolina, United States
Pediatric Specialists Of Virginia
Fairfax, Virginia, United States
STAT Research S A
Buenos Aires, Argentina
Hospital de Ninos de Cordoba
Córdoba, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Huderf
Brussels, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
...and 38 more locations
Time frame: Up to 6 years and 4 months
Number of Participants With AEs of Worsening of the Disease
Number of participants with AEs of worsening of the disease will be reported.
Time frame: Up to 6 years and 4 months
Number of Participants With Concomitant Therapy due to Loss of Response
Number of participants with concomitant therapy due to loss of response will be reported.
Time frame: Up to 6 years and 4 months