Ustekinumab: Ustekinumab will be administered as a SC injection.
Study summary
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
Eligibility
Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria:
* Must have completed the dosing planned in the primary pediatric ustekinumab study
* Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
* Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
* Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration
Exclusion Criteria:
* Are pregnant, nursing, or planning pregnancy or fathering a child
* Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 \[COVID-19\]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit
* Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 \[COVID-19\]) is not automatically an exclusion criterion and must be discussed with the medical monitor
Primary outcome measure(s)
Number of Participants With Adverse Events (AEs) — Up to 6 years and 4 months 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.
Number of Participants With Serious Adverse Events (SAEs) — Up to 6 years and 4 months 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.
Number of Participants with AEs Leading to Discontinuation of Study Intervention — Up to 6 years and 4 months Number of participants with AEs leading to discontinuation of study intervention will be reported.
Number of Participants with AEs of Interest — Up to 6 years and 4 months 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.
Number of Participants with Abnormalities in Clinical Laboratory Parameters — Up to 6 years and 4 months Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.
Number of Participants with Injection-site Reactions — Up to 6 years and 4 months 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.
Number of Participants With AEs of Worsening of the Disease — Up to 6 years and 4 months Number of participants with AEs of worsening of the disease will be reported.
Number of Participants With Concomitant Therapy due to Loss of Response — Up to 6 years and 4 months Number of participants with concomitant therapy due to loss of response will be reported.
Trial sites (48)
Facility
City
Region
Status
Children's Center For Digestive Healthcare, Llc
Atlanta
Georgia
Mount Sinai
New York
New York
Levine Childrens at Atrium Health
Charlotte
North Carolina
Pediatric Specialists Of Virginia
Fairfax
Virginia
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
UZ Brussel
Jette
Belgium
Uz Gasthuisberg
Leuven
Belgium
Hôpital Necker
Paris
France
Universitaetsklinikum der RWTH Aachen
Aachen
Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin
Germany
Semmelweis Egyetem
Budapest
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
Hungary
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc
Hungary
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza
Hungary
Szegedi Tudomanyegyetem
Szeged
Hungary
Yitzhak Shamir Medical Center
Beer Yaakov
Israel
Shaare Zedek Medical Center
Jerusalem
Israel
Sheba Medical Center
Ramat Gan
Israel
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan
Italy
Juntendo University Hospital
Bunkyō City
Japan
Gunma University Hospital
Gunma
Japan
Kindai University Nara Hospital
Ikoma
Japan
Kurume University Hospital
Kurume
Japan
Saitama Childrens Medical Center
Saitama Shi
Japan
Miyagi Childrens Hospital
Sendai
Japan
National Center for Child Health and Development
Setagaya Ku
Japan
Mie University Hospital
Tsu
Japan
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow
Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszów
Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec
Poland
GASTROMED Sp. z o.o.
Torun
Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw
Poland
Medical Network 1
Warsaw
Poland
Medical Network
Warsaw
Poland
Hosp. Univ. I Politecni La Fe
Valencia
Spain
+ 8 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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