Last updated 15 days ago
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
60 patients around the world
Available in Argentina
Janssen Research & Development, LLC
5Research sites
60Patients around the world
This study is for people with
Arthritis
Psoriasic arthritis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made >=3 months (that is, 90 days) prior to screeningActive disease in at least greater than or equal to (>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic jointHave active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intoleranceConcurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable doseParticipants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patientsPrior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period
- Participants with enthesitis-related arthritis (ERA)Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screeningHave a history of, or ongoing, chronic or recurrent infectious diseaseHas evidence of herpes zoster infection within 8 weeks prior to Week 0Have a known history of hepatitis C infection or test positive at screening
Sites
STAT Research - CABA
Recruiting
Centro Médico Privado de Reumatología - San Miguel de Tucumán
Recruiting
Hospital de Niños de la Santísima Trinidad - Córdoba
Recruiting
Instituto Médico Platense SA - La Plata
Recruiting
Instituto CAICI - Rosario, Santa Fe
Recruiting
StudyPSUMMIT-Jr
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Psoriasic arthritis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05083182
