A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

Last Updated   April 24, 2024 - 21:02

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OVERVIEW

  • Gender
    all
  • Age
    2 - 17 years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    31 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

CONDITIONS

  • Arthritis, Psoriatic
  • Colitis, Ulcerative
  • Crohn's Disease

ELIGIBILITY

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

DETAILS

LOCATIONS

Locations in:
United States, United Kingdom, Poland, Japan, Hungary, Germany, France, Belgium, Argentina
Country (9) City or Province (31) Status
United States Atlanta, GA Children's Center For Digestive Healthcare, Llc
RECRUITING
United States New York, NY Mount Sinai
RECRUITING
United Kingdom Birmingham, WMD Birmingham Children's Hospital
RECRUITING
United Kingdom Cambridge, CAM Addenbrookes Hospital
RECRUITING
Poland Krakow Uniwersytecki Szpital Dzieciecy w Krakowie
RECRUITING
Poland Rzeszow Korczowski Bartosz Gabinet Lekarski
RECRUITING
Poland Torun GASTROMED Sp. z o.o.
RECRUITING
Poland Warszawa Instytut Pomnik Centrum Zdrowia
RECRUITING
Poland Warszawa Medical Network
RECRUITING
Japan Bunkyo Ku, 13 Juntendo University Hospital
RECRUITING
Japan Gunma, 10 Gunma University Hospital
RECRUITING
Japan Kurume Kurume University Hospital
RECRUITING
Japan Saitama shi, 11 Saitama Childrens Medical Center
RECRUITING
Japan Sendai, 04 Miyagi Children's Hospital
RECRUITING
Japan Setagaya-ku, 13 National Center for Child Health and Development
RECRUITING
Japan Tsu Mie University Hospital
RECRUITING
Hungary Budapest Semmelweis Egyetem
RECRUITING
Hungary Debrecen Debreceni Egyetem Klinikai Kozpont
RECRUITING
Hungary Miskolc Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
RECRUITING
Hungary Nyiregyhaza Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
RECRUITING
Hungary Szeged Szegedi Tudomanyegyetem
RECRUITING
Germany Aachen Universitaetsklinikum der RWTH Aachen
RECRUITING
Germany Berlin, BE Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
RECRUITING
France Paris Hôpital Necker
RECRUITING
Belgium Bruxelles, BRU Cliniques Universitaires Saint Luc
RECRUITING
Belgium Bruxelles, BRU Huderf
RECRUITING
Belgium Gent UZ Gent
RECRUITING
Belgium Jette, BRU UZ Brussel
RECRUITING
Belgium Leuven Uz Gasthuisberg
RECRUITING
Argentina Cordoba Hospital de Ninos de Cordoba
RECRUITING
Argentina San Miguel De Tucuman Centro de Investigaciones Medicas Tucuman
RECRUITING
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5

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