Condition: Arthritis, Juvenile · Sponsor: Janssen Research & Development, LLC
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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).
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * 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 screening * Active 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 joint * Have 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 intolerance * Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose * Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients * Prior 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 Exclusion Criteria: * Participants with enthesitis-related arthritis (ERA) * Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening * Have a history of, or ongoing, chronic or recurrent infectious disease * Has evidence of herpes zoster infection within 8 weeks prior to Week 0 * Have a known history of hepatitis C infection or test positive at screening
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Childrens Hospital Los Angeles | Los Angeles, California, United States | — |
| UCLA | Los Angeles, California, United States | — |
| Harvard Medical School - Boston Children's Hospital | Boston, Massachusetts, United States | — |
| Northwell Health | New York, New York, United States | — |
| Montefiore Medical Center | The Bronx, New York, United States | — |
| University of North Carolina | Chapel Hill, North Carolina, United States | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States | — |
| Legacy Emanuel Medical Center | Portland, Oregon, United States | — |
| University of Utah | Salt Lake City, Utah, United States | — |
| STAT Research S A | Ciudad Autonoma Buenos Aires, Argentina | — |
| Hospital de Ninos de Cordoba | Córdoba, Argentina | — |
| Instituto Medico Platense | La Plata, Argentina | — |
+ 38 more locations — full list on the registry record.
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