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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959ISD3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-509560-16-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab (Every 8 weeks) | Experimental | Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 [NCT06260163], CNTO1959PBCRD3007 [NCT05923073], CNTO1275JPA3001 [NCT05083182]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks [q8w]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study. |
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| Guselkumab (Every 4 weeks) | Experimental | Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 [NCT06260163], CNTO1959PBCRD3007 [NCT05923073], CNTO1275JPA3001 [NCT05083182]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered as subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety | Treatment-emergent adverse events will be reported to analyze the long-term safety of guselkumab in pediatric participants. | Up to 6 years and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States | |
| Children's Center for Digestive Healthcare |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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
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| Recruiting |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Riley Hospital for Children | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84113 | United States |
| Instituto Caici | Recruiting | Rosario | S2003CVB | Argentina |
| The Kids Research Institute Australia on behalf of the Centre for Child Health Research | Recruiting | Nedlands | 6009 | Australia |
| Mater Hospital Brisbane Inflammatory Bowel Diseases | Recruiting | South Brisbane | 4101 | Australia |
| The Children's Hospital at Westmead | Recruiting | Westmead | 2145 | Australia |
| Universidade Federal de Goias - Hospital das Clinicas da UFG | Recruiting | Goiânia | 74605 020 | Brazil |
| Capital Center For Children's health Capital Medical University | Recruiting | Beijing | 100020 | China |
| Changzhou No 2 Peoples Hospital | Recruiting | Changzhou | 213003 | China |
| The Childrens Hospital Zhejiang University School Of Medicine | Recruiting | Hangzhou | 310005 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | 310016 | China |
| Ruijin Hospital Shanghai Jiao Tong University | Recruiting | Shanghai | 200025 | China |
| Shengjing Hospital Of China Medical University | Recruiting | Shenyang | 110055 | China |
| Hospital Center University De Lille | Recruiting | Lille | 59000 | France |
| Schon Klinik Hamburg Eilbek | Recruiting | Hamburg | 22081 | Germany |
| Asklepios Klinik Sankt Augustin | Recruiting | Sankt Augustin | 53757 | Germany |
| ASST Papa Giovanni XXIII Bergamo | Recruiting | Bergamo | 24127 | Italy |
| Azienda USL di Bologna - Ospedale Maggiore | Recruiting | Bologna | 40121 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesu | Recruiting | Roma | 00165 | Italy |
| Casa Sollievo Della Sofferenza IRCCS | Recruiting | San Giovanni Rotondo | 71013 | Italy |
| IRCCS Materno Infantile Burlo Garofolo | Recruiting | Trieste | 34137 | Italy |
| Tokyo Metropolitan Children's Medical Center | Recruiting | Fuchū | 183 8561 | Japan |
| Kanazawa University Hospital | Recruiting | Kanazawa | 920 8641 | Japan |
| Kobe University Hospital | Recruiting | Kobe | 650 0017 | Japan |
| Japanese Red Cross Kumamoto Hospital | Recruiting | Kumamoto | 861 8520 | Japan |
| Shinshu University Hospital | Recruiting | Matsumoto | 390 8621 | Japan |
| Saga University Hospital | Recruiting | Saga | 849 0937 | Japan |
| Yokohama City University Medical Center | Recruiting | Yokohama | 232 0024 | Japan |
| Korczowski Bartosz Gabinet Lekarski | Recruiting | Rzeszów | 35-302 | Poland |
| Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o | Recruiting | Sosnowiec | 41 200 | Poland |
| Medical Network | Recruiting | Warsaw | 04-501 | Poland |
| Instytut Pomnik Centrum Zdrowia Dziecka | Recruiting | Warsaw | 04-730 | Poland |
| Uls Braga - Hosp. Braga | Recruiting | Braga | 4710 243 | Portugal |
| Uls Sao Joao - Hosp. Sao Joao | Recruiting | Porto | 4200 319 | Portugal |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Hosp. Clinico Univ. de Santiago | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hosp. Univ. I Politecni La Fe | Recruiting | Valencia | 46026 | Spain |
| Gazi University Medical Faculty | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
| Umraniye Training and Research Hospital | Recruiting | Istanbul | 34764 | Turkey (Türkiye) |
| Kocaeli Universitesi Hastanesi | Recruiting | Kocaeli | 41380 | Turkey (Türkiye) |
| Sheffield Children's Hospital | Recruiting | Sheffield | S10 2TH | United Kingdom |
| Royal Stoke University Hospital | Recruiting | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Haywood Hospital | Recruiting | Stoke-on-Trent | ST6 7AG | United Kingdom |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015535 | Arthritis, Psoriatic |
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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