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Um estudo da terapia combinada de guselcumabe e golimumabe em participantes com artrite psoriática ativa (AFFINITY)

25 de junho de 2026 atualizado por: Janssen Research & Development, LLC

Um estudo de fase 2a, multicêntrico, randomizado, duplo-cego avaliando a eficácia e a segurança da terapia combinada de guselcumabe e golimumabe administrado por via subcutânea em participantes com artrite psoriática ativa

O objetivo deste estudo é avaliar a eficácia do tratamento combinado de guselcumabe mais golimumabe em participantes com artrite psoriática ativa (APs) e resposta inadequada (IR) a terapias anteriores anti-fator de necrose tumoral-alfa (anti-TNF-alfa) avaliando resposta clínica em comparação com a monoterapia com guselcumabe.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

A PSA é uma doença inflamatória crônica multifacetada que afeta as articulações periféricas e axiais, tecidos moles e pele. Guselcumabe é um anticorpo monoclonal (mAb) totalmente humano direcionado contra a subunidade p19 da interleucina (IL)-23, bloqueia a ligação da IL-23 extracelular ao receptor de IL-23 da superfície celular, inibindo a sinalização intracelular específica de IL-23, ativação subsequente e produção de citocinas. O golimumabe é um mAb anti-TNF-alfa totalmente humano que se liga ao TNF-alfa com alta afinidade, impede a ligação aos seus receptores, inibindo assim a atividade biológica do TNF-alfa e resultando em produção ou atividade limitada de citocinas inflamatórias, proporcionando assim benefício em vários distúrbios inflamatórios crônicos, incluindo PsA. Este estudo consistirá em uma Fase de Triagem (até 6 semanas), Fase Duplo-cego das Semanas 0 a 24, que inclui a fase de tratamento ativo e a visita de eficácia primária (Semana 24), e Fase de Acompanhamento de Segurança da Semana 24 a Semana 36. As principais avaliações de segurança incluirão eventos adversos (EAs), testes clínicos de segurança laboratorial (hematologia e química), sinais vitais, monitoramento de reações no local da injeção e de hipersensibilidade e detecção precoce de tuberculose ativa (TB). A duração total do estudo é de até 42 semanas.

Tipo de estudo

Intervencional

Inscrição (Real)

91

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Dinamarca
      • Frederiksberg, Dinamarca, 2000
        • Frederiksberg Hospital
      • Glostrup Municipality, Dinamarca, 2600
        • Rigshospitalet Glostrup
      • Køge, Dinamarca, 4600
        • Køge Sygehus Region Sjaelland
      • Silkeborg, Dinamarca, 8600
        • Silkeborg Hospital
      • Vejle, Dinamarca, 7100
        • Vejle Sygehus
  • Espanha
      • A Coruña, Espanha, 15006
        • Hosp Univ A Coruna
      • Barcelona, Espanha, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Bilbao, Espanha, 48013
        • Hosp. Univ. de Basurto
      • Córdoba, Espanha, 14004
        • Hosp Reina Sofia
      • Madrid, Espanha, 28041
        • Hosp. Univ. 12 de Octubre
      • Sabadell, Espanha, 08208
        • Corporacio Sanitari Parc Tauli
      • Santiago de Compostela, Espanha, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Espanha, 41009
        • Hosp. Virgen Macarena
      • Seville, Espanha, 41014
        • Hosp. Ntra. Sra. de Valme
      • Seville, Espanha, 41010
        • Hosp. Infanta Luisa
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85032
        • Arizona Arthritis and Rheumatology Research PLLC
      • Phoenix, Arizona, Estados Unidos, 85037
        • Arizona Arthritis and Rheumatology Research PLLC 1
    • Arkansas
      • Searcy, Arkansas, Estados Unidos, 72143
        • Unity Health-White County Medical Center
    • Florida
      • Avon Park, Florida, Estados Unidos, 33825
        • HARAC Research Corp
      • Bay Pines, Florida, Estados Unidos, 33744
        • Bay Pines VA Healthcare System
      • DeBary, Florida, Estados Unidos, 32713
        • Omega Research Consultants
      • Miami, Florida, Estados Unidos, 33136
        • South Coast Research Center
      • Ocoee, Florida, Estados Unidos, 34761
        • Advanced Clinical Research of Orlando
      • Ormond Beach, Florida, Estados Unidos, 32174
        • Millennium Research
    • Georgia
      • Marietta, Georgia, Estados Unidos, 30060
        • Atlanta Research Center for Rheumatology
    • Michigan
      • Lansing, Michigan, Estados Unidos, 48911
        • Great Lakes Center of Rheumatology
    • Missouri
      • Springfield, Missouri, Estados Unidos, 65807
        • Clinvest
    • New York
      • Brooklyn, New York, Estados Unidos, 11201
        • NYU Langone Ambulatory Care Brooklyn Heights
      • New York, New York, Estados Unidos, 10016
        • NYU School of Medicine
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester
      • The Bronx, New York, Estados Unidos, 10461
        • Jacobi Medical Center
    • Ohio
      • Vandalia, Ohio, Estados Unidos, 45377
        • STAT Research, Inc.
    • Texas
      • Plano, Texas, Estados Unidos, 75024
        • Trinity Universal Research Associates, LLC
      • Tomball, Texas, Estados Unidos, 77375
        • DM Clinical Research
    • Washington
      • Seattle, Washington, Estados Unidos, 98122
        • Swedish Medical Center
  • França
      • Le Mans, França, 72037
        • Centre Hospitalier Le Mans
      • Toulouse, França, 31059
        • Hopital Larrey CHU de Toulouse
      • Tours, França, 37044
        • CHU Trousseau - Service de Rhumatologie
  • Hungria
      • Budapest, Hungria, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Gyula, Hungria, 5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Székesfehérvár, Hungria, 8000
        • Complex Rendelo Med Zrt
      • Veszprém, Hungria, 8200
        • Vital Medical Center
  • Itália
      • Cagliari, Itália, 09124
        • Azienda Ospedaliero-Universitaria di Cagliari
      • Milan, Itália, 20132
        • Ospedale San Raffaele
      • Milan, Itália, 20122
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
      • Pavia, Itália, 27100
        • IRCCS Policlinico San Matteo, Università degli studi di Pavi
      • Reggio Emilia, Itália, 42123
        • Arcispedale Santa Maria Nuova - IRCCS
      • Roma, Itália, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Itália, 00133
        • A.O.U.Policlinico Tor Vergata
      • Rome, Itália, 00128
        • Università Campus Biomedico di Roma
      • Torino, Itália, 10128
        • AO Ordine Mauriziano
  • Polônia
      • Elblag, Polônia, 82-300
        • Centrum Kliniczno Badawcze
      • Lodz, Polônia, 90-242
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Nadarzyn, Polônia, 05-830
        • NZOZ Lecznica MAK MED S C
      • Poznan, Polônia, 61 113
        • Centrum Medyczne
      • Warsaw, Polônia, 00-874
        • Medycyna Kliniczna
      • Warsaw, Polônia, 03 291
        • Centrum Medyczne AMED Targowek
      • Wroclaw, Polônia, 51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • Rússia
      • Kemerovo, Rússia, 650000
        • Kemerovo State Medical University
      • Kemerovo, Rússia, 650070
        • LLL Medical Center Revma-Med
      • Korolyov, Rússia, 141060
        • LLC Family Outpatient Clinic # 4
      • Moscow, Rússia, 129110
        • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
      • Orenburg, Rússia, 460000
        • Orenburg State Medical Academy
      • Rostov-on-Don, Rússia, 344007
        • Rostov Regional Clinical Dermatovenerological Dispensary
      • Ryazan, Rússia, 390046
        • Ryazan Regional Clinical Dermatovenerological Dispensary
      • Saint Petersburg, Rússia, 194156
        • X7 Clinical Research Company Limited
      • Smolensk, Rússia, 214025
        • Smolensk regional hospital on Smolensk railway station
      • Ufa, Rússia, 450005
        • Republican Clinical Hospital - G.G. Kuvatov
      • Yaroslavl, Rússia, 150007
        • Clinical Hospital #3
  • Suécia
      • Malmö, Suécia, 205 02
        • Skånes universitetssjukhus
      • Solna, Suécia, 171 76
        • Karolinska Universitetssjukhuset Solna
  • Ucrânia
      • Kharkiv, Ucrânia, 61039
        • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
      • Kharkiv, Ucrânia, 61204
        • Municipal Institution Regional hospital-center of emergency care and disasters medicine
      • Kyiv, Ucrânia, 03049
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv, Ucrânia, 03680
        • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
      • Kyiv, Ucrânia, 03037
        • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
      • Kyiv, Ucrânia, 04107
        • Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
      • Poltava, Ucrânia, 36011
        • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
      • Ternopil, Ucrânia, 46002
        • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
      • Uzhhorod, Ucrânia, 88000
        • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
      • Vinnytsia, Ucrânia, 21009
        • Health Clinic Limited Liability Company
      • Zaporizhzhya, Ucrânia, 69600
        • Medical Center LLC 'Modern Clinic'

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Ter um diagnóstico de artrite psoriática (PsA) por mais ou igual a (>=) 6 meses antes da primeira administração da intervenção do estudo e atender aos critérios de classificação para PsA (CASPAR) na triagem
  • Ter PsA ativa, definida por ter pelo menos 3 articulações inchadas e pelo menos 3 articulações sensíveis na triagem e na linha de base
  • Ter pelo menos 1 dos seguintes subconjuntos de PsA: envolvimento da articulação interfalângica distal, artrite poliarticular com ausência de nódulos reumatoides, artrite mutilante, artrite periférica assimétrica ou espondilite com artrite periférica
  • Tem psoríase em placas ativa, com pelo menos uma placa psoriática de >=2 centímetros (cm) de diâmetro ou alterações ungueais consistentes com psoríase
  • Ter uma resposta inadequada (IR) à terapia anti-fator de necrose tumoral-alfa (anti-TNF-alfa), definida como a presença de PsA ativa apesar do tratamento com 1 ou 2 agentes anti-TNF-alfa anteriores e os seguintes : uma. Falta de benefício para 1 ou 2 terapias anti-TNF-alfa anteriores, conforme documentado no histórico do participante pelo médico assistente, após pelo menos 12 semanas de terapia com etanercepte, adalimumabe ou certolizumabe pegol, ou pelo menos 14 semanas de infliximabe , ou qualquer biossimilar dessas 4 terapias. A falta documentada de benefício pode incluir melhora inadequada na contagem de articulações, função física ou atividade da doença; b. A última dose da terapia anti-TNF-alfa deve ter ocorrido em mais de 5 meias-vidas do medicamento antes da administração da primeira intervenção do estudo (período de washout)

Critério de exclusão:

  • Tem outras doenças inflamatórias que podem confundir as avaliações de benefício da terapia com guselcumabe e/ou golimumabe, incluindo, entre outros, artrite reumatóide (AR), espondilite anquilosante (EA), espondiloartrite axial não radiográfica (nr AxSpA), lúpus eritematoso sistêmico ou lyme doença
  • Tem intolerância ou hipersensibilidade conhecida a qualquer medicamento biológico, ou alergias conhecidas ou reações clinicamente significativas a proteínas murinas, quiméricas ou humanas, anticorpos monoclonais (mAb) ou fragmentos de anticorpos
  • Recebeu tratamento anterior com golimumabe ou guselcumabe ou tem intolerância documentada à terapia anti-TNF-alfa anterior na história do participante pelo médico assistente
  • Recebeu mais de 2 agentes anti-TNF-alfa anteriores (ou biossimilares)
  • Teste de anticorpos do vírus da imunodeficiência humana (HIV) positivo

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Grupo 1: Guselcumabe e Golimumabe
Os participantes receberão guselcumabe e golimumabe subcutâneos (SC).
Medicamento: Guselcumabe
Guselcumabe será administrado como uma injeção SC.
Outros nomes:
  • CTO1959
  • TREMFYA
Medicamento: Golimumabe
Golimumab será administrado como uma injeção SC.
Outros nomes:
  • SIMPONI
  • CTO148
Comparador Ativo: Grupo 2: Guselcumabe e Placebo
Os participantes receberão SC guselcumabe e placebo.
Medicamento: Guselcumabe
Guselcumabe será administrado como uma injeção SC.
Outros nomes:
  • CTO1959
  • TREMFYA
Medicamento: Placebo
O placebo será administrado como uma injeção SC.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24
Prazo: Week 24
MDA was a measure that defines a satisfactory state of disease activity that includes 5 domains of psoriatic arthritis (PsA) (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of the following 7 criteria at that visit: Tender joint count (68 joints) <=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index (PASI) <=1, Patient's Assessment of Pain <=15 on a 100-unit visual analog scale (VAS), Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, Disability Index of the Health Assessment Questionnaire (HAQ-DI) score <=0.5, and Tender entheseal points <= 1 (Leeds Enthesitis Index [LEI] score <= 1).
Week 24

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 24
Prazo: Week 24
ACR 50 response was defined as greater than or equal to (>=) 50% improvement from baseline in both swollen joint (66 joints) and tender joint counts (68 joints) and >=50% improvement from baseline in >=3 of 5 assessments: Physician global assessment of disease activity (0 to 100 millimeters [mm] VAS [0=no arthritis activity and 100=extremely active arthritis]), Patient global assessment of disease activity (arthritis) (100 mm VAS [0 = no limitation of normal activities; 100 = very poor]), Patient's global assessment of pain (100 mm VAS [0 = no pain; 100 = most severe pain]), patient's assessment of physical function measured by HAQ-DI (20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and high-sensitivity C-reactive protein (hsCRP).
Week 24
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 16
Prazo: Week 16
MDA was a measure that defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of the following 7 criteria at that visit: Tender joint count (68 joints) <=1, Swollen joint count (66 joints) <=1, PASI <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI score <= 1).
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 Among Participants With >= 3% Body Surface Area (BSA) Psoriatic Involvement and an Investigator Global Assessment (IGA) Score of >=2 (Mild) at Baseline
Prazo: Week 24
PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: head and neck, trunk (including axillae and groin), upper extremities, and lower extremities (included buttocks). Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 to 100% involvement), and erythema, induration and scaling, each rated on a scale of 0 to 4, that was none to maximum severity. PASI produces a numeric score range from 0 (no psoriasis) to 72 (worst condition). Higher scores indicated more severe disease.
Week 24
Percentage of Participants Who Achieved PASI 100 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Prazo: Week 24
PASI 100 response was defined as 100% reduction in PASI relative to baseline. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: head and neck, trunk (including axillae and groin), upper extremities, and lower extremities (included buttocks). Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 to 100% involvement), and erythema, induration and scaling, each rated on a scale of 0 to 4, that was none to maximum severity. PASI produces a numeric score range from 0 (no psoriasis) to 72 (worst condition). Higher scores indicated more severe disease.
Week 24
Percentage of Participants With an IGA-psoriasis Response at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Prazo: Week 24
IGA psoriasis response was defined as an IGA psoriasis score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions were graded for induration, erythema, and scaling each using a 5 point scale: clear (0), minimal (1), mild (2), moderate (3), and severe (4). The IGA score of psoriasis was based upon the average of induration, erythema, and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
Prazo: Baseline (Week 0), Week 24
Change from baseline in HAQ-DI score was a measure of the change in the physical function. It consists of a 20-questions instrument that assesses the degree of difficulty a person had in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0 = no difficulty to 3= inability to perform a task. Scores on each task were summed and averaged to provide an overall HAQ-DI total score ranging from 0 (least difficulty) to 3 (extreme difficulty). Lower scores indicated better functioning. Negative change from baseline indicated improvement of physical function.
Baseline (Week 0), Week 24
Percentage of Participants Who Had Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Prazo: Week 24
Enthesitis assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of tenderness by applying local pressure to the following enthesis sites: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. Each site was scored as 1 if tenderness was present or 0 if tenderness was absent. The enthesitis index score was a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Higher score indicated more sites with tenderness. A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI >0.
Week 24
Percentage of Participants Who Achieved Resolution of Dactylitis Response at Week 24 Among the Participants With Dactylitis at Baseline
Prazo: Week 24
Dactylitis was characterized by swelling in both hands and feet. The severity of dactylitis was scored on a scale from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results for each digit summed to produce final dactylitis score which was from 0 to 60. Higher score indicates more severe dactylitis. Dactylitis count was derived based on dactylitis score, each score was recorded to 0 or 1 from 0 to 3, where any score >0 was recorded as 1. For resolution of dactylitis, it was defined as participants who had a dactylitis score greater than 0 at baseline and a score of 0 at the analysis visit.
Week 24
Change From Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24
Prazo: Baseline (Week 0), Week 24
SF-36 was a multi-domain instrument with 36 items to evaluate health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health). The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Domains 1 to 4 primarily contribute to the PCS score of the SF-36. Domains 5-8 primarily contributes to the MCS score of the SF-36. Each of the 8 domain scores and the component summary score ranged from 0=worst to 100=best. Higher scores represent better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Baseline (Week 0), Week 24
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Prazo: From Week 0 up to Week 36
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were any AE occurred at or after the initial administration of study intervention through the day of last dose plus 16 weeks.
From Week 0 up to Week 36
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Prazo: From Week 0 up to Week 36
SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect in the offspring of a participant, or was an important medical event. TESAEs were any SAE occurred at or after the initial administration of study intervention through the day of last dose plus 16 weeks.
From Week 0 up to Week 36
Percentage of Participants With Reasonably Related Adverse Events (AEs)
Prazo: From Week 0 up to Week 36
Percentage of participants with reasonably related AEs was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. AE reasonably related to guselkumab or golimumab were defined as AEs classified by the investigator as related to study agent.
From Week 0 up to Week 36
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Prazo: From Week 0 to Week 20
Percentage of participants with AEs leading to discontinuation of study intervention was reported. AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
From Week 0 to Week 20
Percentage of Participants With Infections
Prazo: From Week 0 up to Week 36
Percentage of participants with infections was reported. Investigators evaluate participants for any signs or symptoms of infection. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product.
From Week 0 up to Week 36
Percentage of Participants With Injection-site Reactions
Prazo: From Week 0 up to Week 36
Percentage of participants with injection-site reaction was reported. A study intervention injection-site reaction was any adverse reaction at a subcutaneous study intervention injection-site. The injection sites were evaluated for reactions, and any injection-site reaction was recorded as an AE. Injection site reactions were significant bruising, erythema, hemorrhage, irritation, pain, and pruritus.
From Week 0 up to Week 36
Group 1: Guselkumab Plus Golimumab - Serum Concentration of Golimumab
Prazo: Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Serum concentration of golimumab was reported.
Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Serum Concentration of Guselkumab
Prazo: Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Serum concentration of guselkumab was reported.
Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Percentage of Participants With Anti-Guselkumab Antibodies
Prazo: From Week 0 up to Week 36
Percentage of participants with anti-guselkumab antibodies was reported.
From Week 0 up to Week 36
Percentage of Participants With Anti-Golimumab Antibodies
Prazo: From Week 0 up to Week 36
Percentage of participants with anti-golimumab antibodies were reported.
From Week 0 up to Week 36

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de outubro de 2021

Conclusão Primária (Real)

14 de maio de 2024

Conclusão do estudo (Real)

6 de agosto de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

6 de setembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de setembro de 2021

Primeira postagem (Real)

8 de outubro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CR109054
  • 2021-002012-31 (Número EudraCT)
  • CNTO1959PSA2003 (Outro identificador: Janssen Research & Development, LLC)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

A política de compartilhamento de dados da Janssen Pharmaceutical Companies of Johnson & Johnson está disponível em www.janssen.com/clinical-trials/transparency. Conforme observado neste site, as solicitações de acesso aos dados do estudo podem ser enviadas por meio do site do Projeto Yale Open Data Access (YODA) em yoda.yale.edu

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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