Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease
Conditions
Brief summary
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
Interventions
DRUGUstekinumab
Ustekinumab will be administered as a SC injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina, Belgium, France, Germany, Hungary, Israel, Italy, Japan, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed