A Long-term Extension Study of Ustekinumab in Pediatric Participants
- Conditions
- Colitis, UlcerativeCrohn DiseaseArthritis, Psoriatic
- Interventions
- Registration Number
- NCT05092269
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 151
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ustekinumab Ustekinumab Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.
- Primary Outcome Measures
Name Time Method 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 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Centro de Investigaciones Medicas Tucuman
🇦🇷San Miguel De Tucuman, Argentina
Huderf
🇧🇪Bruxelles, Belgium
Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
UZ Gent
🇧🇪Gent, 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
🇭🇺Nyiregyhaza, Hungary
Szegedi Tudomanyegyetem
🇭🇺Szeged, Hungary
Yitzhak Shamir Medical Center
🇮🇱Beer Yaakov, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Juntendo University Hospital
🇯🇵Bunkyo Ku, Japan
Gunma University Hospital
🇯🇵Gunma, Japan
Miyagi Children's Hospital
🇯🇵Sendai, Japan
Kurume University Hospital
🇯🇵Kurume, Japan
National Center for Child Health and Development
🇯🇵Setagaya Ku, Japan
Mie University Hospital
🇯🇵Tsu, Japan
Saitama Childrens Medical Center
🇯🇵Saitama shi, Japan
Uniwersytecki Szpital Dzieciecy w Krakowie
🇵🇱Krakow, Poland
Korczowski Bartosz Gabinet Lekarski
🇵🇱Rzeszow, Poland
GASTROMED Sp. z o.o.
🇵🇱Torun, Poland
Medical Network
🇵🇱Warszawa, Poland
Instytut Pomnik Centrum Zdrowia
🇵🇱Warszawa, Poland
Hosp. Univ. I Politecni La Fe
🇪🇸Valencia, Spain
Birmingham Children's Hospital
🇬🇧Birmingham, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
🇮🇹Milano, Italy
Kindai University Nara Hospital
🇯🇵Ikoma, Japan
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
Hospital de Ninos de Cordoba
🇦🇷Cordoba, Argentina