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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275JPA3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-005503-40 | EudraCT Number |
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The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Ustekinumab | Experimental | Participants will receive a weight-based dose of ustekinumab subcutaneously (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52. Cohort 1 is closed for further enrollment. |
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| Cohort 2: Guselkumab | Experimental | The dose of guselkumab will be based on the participant's weight. Participants will receive guselkumab SC at Weeks 0 and 4 followed by either every 4 weeks (Q4W) (with historical radiographic evidence of joint damage) or every 8 weeks (Q8W) (without historical evidence of joint damage) dosing with the last dose at Week 52. Participants at high risk of joint damage can also be considered for Q4W dosing per investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Ustekinumab will be administered as subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups | Steady-state trough serum concentration of ustekinumab at Week 28 by baseline age groups will be reported. | Week 28 |
| Cohort 2: Steady-state Trough Serum Concentration of Guselkumab at Week 28 by Baseline Age Groups | Steady-state trough serum concentration of guselkumab at Week 28 by baseline age groups will be reported. | Week 28 |
| Cohort 1: Area Under the Curve at Steady-state (AUCss) Over a 12-Week Dosing Interval of Ustekinumab at Week 28 by Baseline Age Groups | AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 28 by baseline age groups. | Week 28 |
| Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 28 by Baseline Age Groups | AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 28 by baseline age groups. | Week 28 |
| Cohort 1: Percentage of Participants with Juvenile Psoriatic Arthritis (jPsA) Achieving American College of Rheumatology (ACR) Pediatric 30 Response at Week 24 | Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30 percent (%) improvement (that is, a decrease in score) from baseline in greater than or equal to (>=) 3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: physician global assessment (PGA) of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by childhood health assessment questionnaire (CHAQ) and C-reactive protein (CRP). |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 52 by Baseline Age Groups | Steady-state trough serum concentration of ustekinumab at Week 52 by baseline age groups will be reported. | Week 52 |
| Cohorts 2: Steady-state Trough Serum Concentration of Guselkumabat at Week 52 by Baseline Age Groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| UCLA |
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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| Guselkumab | Drug | Guselkumab will be administered as subcutaneous injection. |
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| Week 24 |
| Cohort 2: Percentage of Participants with jPsA Achieving ACR Pediatric 30 Response at Week 24 | Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in >=3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP. | Week 24 |
Steady-state trough serum concentration of guselkumab at Week 52 by baseline age groups will be reported. |
| Week 52 |
| Cohort 1: AUCss Over a 12-Week Dosing Interval of Ustekinumab at Week 52 by Baseline Age Groups | AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 52 by baseline age groups. | Week 52 |
| Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 52 by Baseline Age Groups | AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 52 by baseline age groups. | Week 52 |
| Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 30 Response at Weeks 4, 8, 12, 16, and 52 | The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in >=3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP. | Weeks 4, 8, 12, 16 and 52 |
| Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 50 and 70 Responses at Weeks 4, 8, 12, 16, 24, and 52 | The ACR pediatric 50 and 70 responses are defined as a 50% improvement or 70% improvement (that is, a decrease in score) from baseline in >=3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP. | Weeks 4, 8, 12, 16, 24, and 52 |
| Cohorts 1 and 2: Time to Response Measured as Time to Achieving ACR Pediatric 30 | Time to response measured as time to achieving ACR pediatric 30 will be reported. | Baseline, up to Week 24 |
| Cohorts 1 and 2: Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS) 10 at Weeks 4, 8, 12, 16, 24, and 52 | Change from baseline in cJADAS 10 at Weeks 4, 8, 12, 16, 24, and 52 will be reported. The cJADAS is calculated as the sum of the scores of its 3 components: (1) physician global rating of overall disease activity, measured on a 10-cm horizontal visual analog scale; (2) parent/child ratings of well-being, assessed on a 10 cm horizontal line VAS; (3) number of active joints, assessed in 10 joints, for a total score ranging from 0 to 30 where 0=no activity and 30=maximum activity. | Baseline, up to Weeks 4, 8, 12, 16, 24, and 52 |
| Cohorts 1 and 2: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 10, 27 and 71 at Weeks 4, 8, 12, 16, 24, and 52 | Change from baseline in JADAS 10, 27 and 71 at Weeks 4, 8, 12, 16, 24, and 52 will be reported. The JADAS is calculated as the sum of the scores of its 4 components: (1) physician global rating of overall disease activity, measured on a 10-cm horizontal visual analog scale; (2) parent/child ratings of well-being, assessed on a 10 cm horizontal line VAS; (3) number of active joints, assessed in 71, 27, or 10 joints (for JADAS 71, JADAS 27, and JADAS 10, respectively); (4) CRP (truncated to 0-10 mg/dL). | Baseline, up to Weeks 4, 8, 12, 16, 24, and 52 |
| Cohorts 1 and 2: Change from Baseline in Psoriasis Area Severity Index (PASI) Score at Week 24 | Change from baseline in PASI score at Week 24 among the participants with greater than or equal to (>=) 3% body surface area (BSA) psoriatic involvement and a PGA psoriasis score of >=2 (mild) at baseline will be reported. The PASI includes assessments of 4 areas of the body: the head and neck, the arms, the trunk, and the legs. The percentage of skin in each area affected by psoriasis is given a numeric score representing the proportion involved. The severity of the 3 plaque signs of erythema, thickness/induration, and desquamation/scaling, is assessed on a 5-point scale. The total PASI score is from 0-72, where 0=no disease and 72=more disease. | Baseline and Week 24 |
| Cohorts 1 and 2: Percentage of Participants with Adverse Events (AEs) | 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 Week 68 |
| Cohorts 1 and 2: Percentage of Participants with Serious Adverse Events (SAEs) | A SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | Up to Week 68 |
| Cohorts 1 and 2: Percentage of Participants with Reasonably Related AEs | Percentage of participants with reasonably related AEs (including injection-site reactions and infections) will be reported. | Up to Week 68 |
| Cohorts 1: Number of Participants with Antibodies to Ustekinumab | Number of participants with antibodies to ustekinumab (including peak titers) will be reported. | Weeks 52 and 68 |
| Cohorts 2 : Number of Participants with Antibodies to Guselkumab | Number of participants with antibodies to guselkumab (including peak titers) will be reported. | Weeks 52 and 68 |
| Los Angeles |
| California |
| 90095-3075 |
| United States |
| Harvard Medical School - Boston Children's Hospital | Boston | Massachusetts | 02215-5450 | United States |
| Northwell Health | New York | New York | 11040 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467-2403 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Legacy Emanuel Medical Center | Portland | Oregon | 97227 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| STAT Research S A | Ciudad Autonoma Buenos Aires | C1013AAAB | Argentina |
| Hospital de Ninos de Cordoba | Córdoba | 5000 | Argentina |
| Instituto Medico Platense | La Plata | B1900 | Argentina |
| Instituto Caici | Rosario | S2000PBJ | Argentina |
| Centro Medico Privado de Reumatologia | San Miguel de Tucumán | T4000AXL | Argentina |
| Aarhus Universitetshospital | Aarhus | 8200 | Denmark |
| Odense Universitets Hospital | Odense | 5000 | Denmark |
| CHU de Caen | Caen | 14033 | France |
| Hopital de Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| Hopital Nord Marseille | Marseille | 13015 | France |
| CHU de Toulouse Hopital des Enfants | Toulouse | 31059 | France |
| Hôpital D'Enfants | Vandœuvre-lès-Nancy | 54511 | France |
| Charite Universitatsmedizin Berlin Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Schon Klinik Hamburg Eilbek | Hamburg | 22081 | Germany |
| Asklepios Klinik Sankt Augustin | Sankt Augustin | 53757 | Germany |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili | Brescia | 25100 | Italy |
| Istituto Giannina Gaslini | Genova | 16147 | Italy |
| Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO | Milan | 20122 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesu | Roma | 00165 | Italy |
| CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej | Lodz | 91-738 | Poland |
| Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o | Sosnowiec | 41 200 | Poland |
| Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher | Warsaw | 02 637 | Poland |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 8041 | Spain |
| Hosp Reina Sofia | Córdoba | 14004 | Spain |
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hosp. Infanta Luisa | Seville | 41010 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| Hacettepe Universitesi Hastanesi | Ankara | 6230 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Umraniye Training and Research Hospital | Istanbul | 34766 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Great Ormond Street Hospital | London | WC1N 3JH | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | M13 9WL | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Sheffield Children's Hospital | Sheffield | S10 2TH | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Haywood Hospital | Staffordshire | ST6 7AG | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| C000588857 | guselkumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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