소아 참가자에 대한 Ustekinumab의 장기 확장 연구 (UNITED)
소아 임상 연구 참가자(2~
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Aachen, 독일, 52074
- Universitaetsklinikum der RWTH Aachen
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Berlin, 독일, 13353
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Georgia
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Atlanta, Georgia, 미국, 30342
- Children's Center For Digestive Healthcare, Llc
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New York
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New York, New York, 미국, 10029
- Mount Sinai
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North Carolina
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Charlotte, North Carolina, 미국, 28207
- Levine Childrens at Atrium Health
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Virginia
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Fairfax, Virginia, 미국, 22031
- Pediatric Specialists Of Virginia
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Brussels, 벨기에, 1200
- Cliniques Universitaires Saint Luc
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Brussels, 벨기에, 1020
- Huderf
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Ghent, 벨기에, 9000
- UZ Gent
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Jette, 벨기에, 1090
- UZ Brussel
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Leuven, 벨기에, 3000
- Uz Gasthuisberg
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Valencia, 스페인, 46026
- Hosp. Univ. I Politecni La Fe
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Buenos Aires, 아르헨티나, C1060
- STAT Research S A
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Córdoba, 아르헨티나, X5014FTO
- Hospital de Ninos de Cordoba
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San Miguel de Tucumán, 아르헨티나, T4000AXL
- Centro de Investigaciones Medicas Tucuman
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Birmingham, 영국, B4 6NH
- Birmingham Children's Hospital
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Cambridge, 영국, Cb2 2qq
- Addenbrookes Hospital
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London, 영국, E1 1BB
- Royal London Hospital
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London, 영국, WC1N 3JH
- Great Ormond Street Hospital
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Sheffield, 영국, S10 2TH
- Sheffield Children's Hospital
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Southampton, 영국, SO16 6YD
- Southampton University Hospital
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Beer Yaakov, 이스라엘, 70300
- Yitzhak Shamir Medical Center
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Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
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Ramat Gan, 이스라엘, 5266202
- Sheba Medical Center
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Milan, 이탈리아, 20122
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Bunkyō City, 일본, 113 8431
- Juntendo University Hospital
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Gunma, 일본, 371-0034
- Gunma University Hospital
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Ikoma, 일본, 630 0293
- Kindai University Nara Hospital
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Kurume, 일본, 830-0011
- Kurume University Hospital
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Saitama Shi, 일본, 330-8777
- Saitama Childrens Medical Center
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Sendai, 일본, 989-3126
- Miyagi Childrens Hospital
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Setagaya Ku, 일본, 157 8535
- National Center for Child Health and Development
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Tsu, 일본, 514 8507
- Mie University Hospital
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Ankara, 터키 (Türkiye), 06230
- Hacettepe University Medical Faculty
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Istanbul, 터키 (Türkiye), 34098
- Cerrahpasa Medical Faculty Hospital
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Krakow, 폴란드, 30 663
- Uniwersytecki Szpital Dzieciecy w Krakowie
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Rzeszów, 폴란드, 35-302
- Korczowski Bartosz Gabinet Lekarski
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Sosnowiec, 폴란드, 41 200
- Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
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Torun, 폴란드, 87 100
- GASTROMED Sp. z o.o.
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Warsaw, 폴란드, 04 730
- Instytut Pomnik Centrum Zdrowia Dziecka
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Warsaw, 폴란드, 04-501
- Medical Network
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Warsaw, 폴란드, 04-501
- Medical Network 1
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Paris, 프랑스, 75015
- Hôpital Necker
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Budapest, 헝가리, 1083
- Semmelweis Egyetem
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Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
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Miskolc, 헝가리, 3526
- Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
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Nyíregyháza, 헝가리, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Szeged, 헝가리, 6720
- Szegedi Tudomanyegyetem
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
Ustekinumab will be administered as a SC injection.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Adverse Events (AEs)
기간: Up to 6 years and 4 months
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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. |
Up to 6 years and 4 months
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Number of Participants With Serious Adverse Events (SAEs)
기간: Up to 6 years and 4 months
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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. |
Up to 6 years and 4 months
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Number of Participants with AEs Leading to Discontinuation of Study Intervention
기간: Up to 6 years and 4 months
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Number of participants with AEs leading to discontinuation of study intervention will be reported. |
Up to 6 years and 4 months
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Number of Participants with AEs of Interest
기간: Up to 6 years and 4 months
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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. |
Up to 6 years and 4 months
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Number of Participants with Abnormalities in Clinical Laboratory Parameters
기간: Up to 6 years and 4 months
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Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported. |
Up to 6 years and 4 months
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Number of Participants with Injection-site Reactions
기간: Up to 6 years and 4 months
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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. |
Up to 6 years and 4 months
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Number of Participants With AEs of Worsening of the Disease
기간: Up to 6 years and 4 months
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Number of participants with AEs of worsening of the disease will be reported. |
Up to 6 years and 4 months
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Number of Participants With Concomitant Therapy due to Loss of Response
기간: Up to 6 years and 4 months
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Number of participants with concomitant therapy due to loss of response will be reported. |
Up to 6 years and 4 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR109074
- 2020-004457-76 (EudraCT 번호)
- CNTO1275ISD3001 (기타 식별자: Janssen Research & Development, LLC)
- 2022-501067-40-00 (레지스트리 식별자: EUCT number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .