Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

NCT05083182

CompletedPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Arthritis, Juvenile

Interventions: Ustekinumab, Guselkumab

Countries: United States, Argentina, Denmark, France, Germany, Italy, Poland, Spain

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).

Eligibility overview

Sex: ALL

Age: 5 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (50)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Portland, Oregon, United States
  • Salt Lake City, Utah, United States
  • Ciudad Autonoma Buenos Aires, Argentina
  • Córdoba, Argentina
  • La Plata, Argentina
  • Rosario, Argentina
  • San Miguel de Tucumán, Argentina
  • Aarhus, Denmark
  • Odense, Denmark
  • Caen, France
  • Le Kremlin-Bicêtre, France
  • Marseille, France
  • Toulouse, France
  • Vandœuvre-lès-Nancy, France
  • Berlin, Germany
  • Hamburg, Germany
  • Sankt Augustin, Germany
  • Brescia, Italy
  • Genova, Italy
  • Milan, Italy
  • Milan, Italy
  • Roma, Italy
  • Lodz, Poland
  • + 20 more on CT.gov