Study on the Effects of Risankizumab and Adalimumab in 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 a medication called risankizumab in children with a condition known as juvenile psoriatic arthritis. Juvenile psoriatic arthritis is a type of arthritis that affects children and is associated with a skin condition called psoriasis, which causes red, scaly patches on the skin. The study will also compare risankizumab to another medication called adalimumab, which is already used to treat this condition. Both medications are given as injections under the skin.

The purpose of the study is to evaluate how well risankizumab works, how safe it is, and how it is processed by the body in children aged 5 to under 18 years who have active juvenile psoriatic arthritis. These children may not have responded well to other treatments like methotrexate or similar medications. Participants in the study will receive either risankizumab or adalimumab, and their progress will be monitored over a period of time to see how their symptoms change.

The study will last for about 124 weeks, during which time participants will have regular check-ups to assess their response to the treatment. The main goal is to see if the children achieve a significant improvement in their arthritis symptoms by the 24th week of the study. Additional assessments will be made to measure changes in pain levels, skin symptoms, and overall disease activity. This information will help determine the effectiveness and safety of risankizumab for treating juvenile psoriatic arthritis in children.

1 joining the study

Upon joining the study, the patient will be assessed to confirm a diagnosis of juvenile psoriatic arthritis. This includes having active disease in at least three joints.

The patient must have previously shown an inadequate response or intolerance to certain medications such as methotrexate or other similar treatments.

2 initial treatment phase

The patient will begin treatment with either risankizumab or adalimumab. Both medications are administered as a solution for injection under the skin.

The specific dosage and frequency of administration will be determined by the study protocol and the patient’s individual needs.

3 monitoring and assessment

Throughout the study, the patient’s response to the medication will be closely monitored. This includes regular assessments of joint activity and overall health.

The primary goal is to achieve a significant improvement in symptoms by Week 24, as measured by specific criteria for juvenile arthritis.

4 evaluation of treatment effectiveness

At Week 24, the patient’s progress will be evaluated to determine the effectiveness of the treatment. This includes measuring changes in joint activity and other health indicators.

Secondary outcomes will also be assessed, such as improvements in pain levels and skin symptoms if applicable.

5 continuation or adjustment of treatment

Based on the results at Week 24, the treatment plan may be continued or adjusted to better meet the patient’s needs.

The study aims to provide ongoing support and monitoring to ensure the best possible outcomes for the patient.

Who Can Join the Study?

The patient must have been diagnosed with Juvenile Psoriatic Arthritis (jPsA), which is a type of arthritis that affects children, for at least 6 months before the start of the study.
The patient must have active disease in 3 or more joints at the time of screening and at the beginning of the study. Active disease means the joints are swollen (not due to deformity) or have limited movement with pain or tenderness.
The patient must have tried treatment with at least one of the following medications and found them not effective or could not tolerate them: Methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine. These are medications used to treat arthritis.
The patient must be between the ages of 5 and less than 18 years old.
Both male and female patients can participate in the study.

Who Cannot Join the Study?

Patients who have not had an inadequate response to, or are not intolerant of, methotrexate (MTX) or other csDMARDs cannot participate. Methotrexate (MTX) is a medication used to treat certain types of arthritis, and csDMARDs are a group of drugs that slow down the disease process in arthritis.
Patients who are not within the age range of 5 to less than 18 years cannot participate.
Patients who do not have active Juvenile Psoriatic Arthritis cannot participate. Juvenile Psoriatic Arthritis is a type of arthritis that affects children and is associated with a skin condition called psoriasis.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Uniwersytecki Szpital Dzieciecy W Lublinie	Lublin	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Pellegrin Hospital	Bordeaux	France
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Asklepios Klinik Sankt Augustin GmbH	Sankt Augustin	Germany
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.	Sosnowiec	Poland
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Hldtfztwy Zffeypb ftzq Kbfbyok uzh Jsnbfrglbxhczmeljto	Hamburg	Germany
Njngxkqg Itnfsgts Ggxzzygms Redjdulouxaq I Rflbnilfrfxav It Pepag Dg Hnat Mmre Eykhycag Rwkqpvm	Warsaw	Poland
Ccl Kjqrlxp Bnyiclv	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	08.04.2024
Germany	Recruiting	08.04.2024
Italy	Recruiting	08.04.2024
Poland	Recruiting	08.04.2024
Spain	Recruiting	08.04.2024

Trial locations

Investigated drugs:

Risankizumab is a medication being studied for its effectiveness, safety, and tolerability in treating children with active juvenile psoriatic arthritis. It is administered through an injection under the skin and is being compared to another treatment to see how well it works in reducing symptoms of the condition.

Adalimumab is used as a reference treatment in this study. It is a well-known medication for treating various inflammatory conditions, including juvenile psoriatic arthritis. It helps reduce inflammation and relieve symptoms by targeting specific proteins in the immune system.

Methotrexate is a medication that some participants in the study may have previously used. It is commonly prescribed for juvenile psoriatic arthritis to help control inflammation and slow down the progression of the disease. However, some children may not respond well to it or may experience side effects, which is why alternative treatments are being explored in this trial.

Investigated diseases:

Juvenile psoriatic arthritis

Juvenile Psoriatic Arthritis – This is a type of arthritis that affects children and adolescents, typically characterized by joint inflammation and skin symptoms similar to psoriasis. It can cause swelling, stiffness, and pain in the joints, often accompanied by patches of red, scaly skin. The disease may 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 can vary greatly in severity and may affect different joints in the body.

Trial ID:

2023-506026-36-00

Protocol code:

M23-732

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Risankizumab and Adalimumab in Children with Active Juvenile Psoriatic Arthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?