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
151
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
ACTIVE_NOT_RECRUITINGMount Sinai
New York, New York, United States
COMPLETEDLevine Childrens at Atrium Health
Charlotte, North Carolina, United States
ACTIVE_NOT_RECRUITINGPediatric Specialists Of Virginia
Fairfax, Virginia, United States
ACTIVE_NOT_RECRUITINGSTAT Research S A
Buenos Aires, Argentina
RECRUITINGHospital de Ninos de Cordoba
Córdoba, Argentina
RECRUITINGCentro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
RECRUITINGHuderf
Brussels, Belgium
COMPLETEDCliniques Universitaires Saint Luc
Brussels, Belgium
ACTIVE_NOT_RECRUITINGUZ Gent
Ghent, Belgium
COMPLETED...and 37 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