Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Last updated: February 25, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

Placebo

Apremilast

Clinical Study ID

NCT04804553
20190529
  • Ages 5-17
  • All Genders

Study Summary

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female participants 5 to < 18 years of age at the time of randomization.

  • Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA)according to the International League of Associations for Rheumatology (ILAR)Edmonton Revision (Petty, 2001) classification criteria of at least 6 monthsduration:

  • Arthritis and psoriasis, OR

  • Arthritis with at least 2 of the following:

  • Dactylitis

  • Nail pitting or onycholysis

  • Psoriasis in a first-degree relative

  • Active disease: at least 3 active joints (including distal interphalangeal joints).

  • Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifyinganti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologicagents).

Exclusion

Exclusion Criteria:

  • Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:

  • Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age

  • Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter'ssyndrome, acute anterior uveitis, or a history of one of these disorders in afirst-degree relative

  • History of IgM rheumatoid factor on at least 2 occasions at least 3 monthsapart

  • Presence of systemic juvenile idiopathic arthritis (JIA).

  • Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, butnot limited to: systemic lupus erythematosus, mixed connective tissue disease,scleroderma, polymyositis, or fibromyalgia.

  • Prior history of or current inflammatory joint disease other than PsA (eg, gout,reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 17, 2022
Estimated Completion Date:
December 29, 2028

Connect with a study center

  • Landeskrankenhaus Bregenz

    Bregenz, 6900
    Austria

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Regional de la Citadelle

    Liege, 4000
    Belgium

    Terminated

  • Ziekenhuis Netwerk Antwerpen Jan Palfijn

    Merksem, 2170
    Belgium

    Terminated

  • Hospices Civils de Lyon Hopital Femme Mere Enfant

    Bron cedex, 69677
    France

    Active - Recruiting

  • Hopital Jeanne de Flandre

    Lille, 59037
    France

    Active - Recruiting

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitaetsklinik Carl Gustav Carus

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • An der Schoen Klinik Hamburg Eilbek

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Asklepios Kinderklinik Sankt Augustin GmbH

    Sankt Augustin, 53757
    Germany

    Completed

  • Agia Sofia Children Hospital

    Athens, 11527
    Greece

    Active - Recruiting

  • Attikon University General Hospital

    Athens, 12462
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki Ippokrateio

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • Ospedale Santissima Annunziata

    Chieti, 66100
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genova, 16147
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

    Milano, 20122
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Active - Recruiting

  • Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine

    Vilnius, 08406
    Lithuania

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 EA
    Netherlands

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie

    Krakow, 31-503
    Poland

    Active - Recruiting

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 91-738
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warszawa, 02-637
    Poland

    Active - Recruiting

  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisboa, 1349-019
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisboa, 1349-019
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Centro Hospitalar Universtario de Sao Joao, EPE

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

    Porto, 4200-319
    Portugal

    Terminated

  • Spitalul Clinic de Urgenta pentru Copii Cluj

    Cluj-Napoca, 400124
    Romania

    Active - Recruiting

  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

    Timisoara, 300011
    Romania

    Active - Recruiting

  • Panorama Medical Centre

    Panorama, Western Cape 7500
    South Africa

    Active - Recruiting

  • Groote Schuur Hospital

    Cape Town, 7700
    South Africa

    Terminated

  • Hospital Universitario de Canarias

    La Laguna, Canarias 38320
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Cataluña 08035
    Spain

    Active - Recruiting

  • Hospital Sant Joan de Deu

    Esplugues De Llorbregat, Cataluña 08950
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, Comunidad Valenciana 46026
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Terminated

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Umraniye Egitim ve Arastirma Hastanesi

    Istanbul, 34764
    Turkey

    Active - Recruiting

  • Birmingham Childrens Hospital

    Birmingham, B4 6NH
    United Kingdom

    Active - Recruiting

  • Alder Hey Childrens Hospital

    Liverpool, L12 2AP
    United Kingdom

    Terminated

  • Nottingham Childrens Hospital

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

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