Study on Ustekinumab and Guselkumab for Children with Active Juvenile Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying the effects of two medications, Ustekinumab and Guselkumab, in children and teenagers with Juvenile Psoriatic Arthritis. Juvenile Psoriatic Arthritis is a type of arthritis that affects children and is associated with the skin condition psoriasis, which causes red, scaly patches on the skin. The purpose of the study is to evaluate how well these medications work, how safe they are, and how the body processes them when given as an injection under the skin.

Participants in the study will receive either Ustekinumab or Guselkumab over a period of up to 52 weeks. The study will monitor the participants’ response to the treatment, including any changes in their arthritis symptoms and any side effects they may experience. The study will also look at how the body absorbs and breaks down the medications, which is known as pharmacokinetics. This information will help determine the best dosage and frequency for these medications in treating Juvenile Psoriatic Arthritis.

Throughout the study, participants will have regular check-ups to assess their health and the effectiveness of the treatment. The study aims to provide valuable information on the use of Ustekinumab and Guselkumab in young patients with Juvenile Psoriatic Arthritis, potentially leading to better treatment options for managing this condition. The study will also gather data on the immune response to these medications, which is important for understanding their long-term safety and effectiveness.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 5 and 18 years and a diagnosis of juvenile psoriatic arthritis.

The assessment checks for active disease in at least three joints and previous treatment history with non-biologic DMARDs or NSAIDs.

2 medication administration

Participants receive either ustekinumab or guselkumab through subcutaneous injections. The specific medication and dosage depend on the study group assignment.

Ustekinumab is administered as a 45 mg or 90 mg solution, while guselkumab is provided as a 100 mg/mL solution.

3 treatment schedule

The treatment involves regular injections over a specified period. Ustekinumab is given every 12 weeks, while guselkumab is administered every 4 or 8 weeks.

The schedule is designed to maintain steady levels of the medication in the body.

4 monitoring and evaluation

Participants undergo regular monitoring to evaluate the effectiveness and safety of the treatment. This includes measuring the response to treatment and checking for any side effects.

Assessments occur at various intervals, such as Weeks 4, 8, 12, 16, 24, and 52, to track progress and adjust treatment if necessary.

5 final assessment

At the end of the study period, a final assessment is conducted to evaluate the overall outcomes of the treatment.

This includes measuring the long-term effects on joint health and any potential development of antibodies against the medications.

Who Can Join the Study?

  • Must be between 5 and 17 years old.
  • Must have a diagnosis of juvenile psoriatic arthritis (jPsA). This means having arthritis and psoriasis, or arthritis and at least two of the following: dactylitis (swelling of fingers or toes), nail pits (small dents in the nails), a family history of psoriasis, or a rash that looks like psoriasis.
  • Must have active disease in at least three joints. This means the joints are swollen or have limited movement with pain or tenderness.
  • Must have active disease even after trying non-biologic DMARD (disease-modifying antirheumatic drugs) for at least 12 weeks or showing intolerance, and/or NSAID (non-steroidal anti-inflammatory drugs) for at least 4 weeks or showing intolerance.
  • If previously treated with an anti-TNFα agent (a type of medication for inflammation) or other biologic agents, these should have been stopped before starting the study, following specific guidelines for how long to wait after stopping the medication.

Who Cannot Join the Study?

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently taking medications that might affect the study results.
  • Patients who have had a recent infection or illness that could impact their participation.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of substance abuse.
  • Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Des Enfants Toulouse France
IRCCS Istituto Giannina Gaslini Genoa Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
Universita Degli Studi Di Brescia Brescia Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Centre Hospitalier Universitaire De Caen Normandie Caen France
Bicetre Hospital Le Kremlin-Bicetre France
Stffux Ksrxyh Hdqvmjs Eftcxi Hamburg Germany
Nxwuycbw Ihlxsndj Gelvooikc Rnnahmyvapbp I Rvvxbttpsitfv Ix Pmftk Dm Hiiz Meur Ejexbwpr Rxcafvb Warsaw Poland
Ajjmhwclvc Pwvnnpyw Hioklkog Dl Mswuphzsf Marseille France
Eusxhhn Urnrvxusxvcc Mhuwfds Czseifl Rqxnrnkcc (gemhmlh Msb Rotterdam The Netherlands
Ablfel Uknevkxxsg Hsgirxhs Aarhus Denmark
Crjy Dt Npohq Vandoeuvre Les Nancy France
Htggmmoo Dx Lb Swjbz Cupn I Shgs Ppv Barcelona Spain
Hyjyylci Vqwg dlprtspc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
21.06.2023
France France
Not recruiting
21.06.2023
Germany Germany
Not recruiting
21.06.2023
Italy Italy
Not recruiting
21.06.2023
Poland Poland
Not recruiting
21.06.2023
Spain Spain
Not recruiting
21.06.2023
The Netherlands The Netherlands
Not recruiting
21.06.2023

Trial locations

Investigated drugs:

Ustekinumab is a medication used in this trial to treat children with active juvenile psoriatic arthritis. It works by targeting specific proteins in the immune system that contribute to inflammation and the symptoms of arthritis. The goal is to reduce joint pain and swelling, improve physical function, and slow down joint damage.

Guselkumab is another medication being tested in the trial for its effectiveness in treating juvenile psoriatic arthritis. Like ustekinumab, it targets certain proteins in the immune system to help reduce inflammation and alleviate the symptoms associated with the condition. The study aims to assess how well it works in improving the health and quality of life for children with this type of arthritis.

Juvenile Psoriatic Arthritis – Juvenile psoriatic arthritis is a type of inflammatory arthritis that affects children and is associated with the skin condition psoriasis. It typically causes joint pain, swelling, and stiffness, often in the fingers and toes, and may also lead to changes in the nails. The disease can progress with periods of increased symptoms, known as flares, and periods of remission where symptoms improve. Over time, it can lead to joint damage if not managed properly. The condition may also involve other symptoms such as fatigue and eye inflammation. It is considered a rare disease in the pediatric population.

Trial ID:
2023-507144-36-00
Protocol code:
CNTO1275JPA3001
NCT ID:
NCT05083182
Trial Phase:
Therapeutic confirmatory (Phase III)

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