Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification c
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: - Males or females 2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: - 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: may be included with a documented negative result for a validated SARS-CoV-2 test (i) obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, eg, 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 NOTES on COVID-related exclusion: - The field of COVID-related testing (for presence of, and immunity to, the SARS-CoV-2 virus) is rapidly evolving. Additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations/guidance from authorities/standards of care Precaution: for those who may carry a higher risk for severe COVID-19 illness, follow guidance from local health authorities when weighing the potential benefits and risks of enrolling in the study, and during participation in the study (protocol Appendix 8 [Section 10.8]). - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, 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 SARS CoV-2 vaccine (against the virus that causes COVID-19) is not automatically an exclusion criterion and must be discussed with the medical monitor. Please refer to study protocol section 5.2 for full list of exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Long-term safety data;Secondary Objective: Not applicable;Primary end point(s): - AEs, SAEs, AEs leading to discontinuation of study intervention, and AEs of special interest (as determined for each indication). - Clinical laboratory hematology and chemistry. - Injection-site reactions - AEs of worsening of the disease under study. - An addition of concomitant therapy due to loss of response.;Timepoint(s) of evaluation of this end point: Enrolment through to end of study participation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Belgium, France, Germany, Hungary, Italy, Japan, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed