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Набира участници Фаза 3 NCT06100744

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Фаза 3 – широко изпитване преди одобрение
Заболявания: Juvenile Psoriatic Arthritis

Спонсор: AbbVie

Налично на: БГ
Обобщение
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Кой може да участва
Inclusion Criteria: * Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening. * Active Disease in \>= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study. * Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine. Exclusion Criteria: * Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis \[JIA\], rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome. * Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes.
Места на провеждане 9
Австралия (1)
Monash Health - Monash Medical Centre /ID# 260255
Clayton , Victoria
Канада (1)
Alberta Children's Hospital /ID# 257880
Calgary , Alberta
Франция (1)
CHU Bordeaux - Hopital Pellegrin /ID# 258729
Bordeaux , New Aquitaine
Германия (1)
Asklepios Klinik Sankt Augustin /ID# 259106
Sankt Augustin , North Rhine-Westphalia
Site Coordinator
Италия (1)
Azienda Ospedaliero Universitaria Meyer /ID# 258587
Florence , Firenze
Полша (1)
Malopolskie Badania Kliniczne /ID# 258777
Cracow , Lesser Poland Voivodeship
Испания (1)
Hospital Sant Joan de Deu /ID# 257568
Esplugues de Llobregat , Barcelona
Великобритания (1)
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
Sheffield , England
САЩ (1)
Arkansas Children's Hospital /ID# 258776
Little Rock , Arkansas
Site Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
5 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
08.07.2024
Крайна дата
01.10.2028
Регистрационен номер
NCT06100744
Източник
anzctr
Запитване за медицински туризъм

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