Un estudio de terapia combinada de guselkumab y golimumab en participantes con artritis psoriásica activa (AFFINITY)
25 de junio de 2026 actualizado por: Janssen Research & Development, LLC
Un estudio de fase 2a, multicéntrico, aleatorizado, doble ciego que evalúa la eficacia y la seguridad de la terapia combinada de guselkumab y golimumab administrados por vía subcutánea en participantes con artritis psoriásica activa
El propósito de este estudio es evaluar la eficacia del tratamiento combinado de guselkumab más golimumab en participantes con artritis psoriásica (APs) activa y respuesta inadecuada (IR) a terapias previas con factor de necrosis tumoral alfa (anti-TNF-alfa) evaluando respuesta clínica en comparación con la monoterapia con guselkumab.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
La PsA es una enfermedad inflamatoria crónica multifacética que afecta las articulaciones periféricas y axiales, los tejidos blandos y la piel.
Guselkumab es un anticuerpo monoclonal (mAb) completamente humano dirigido contra la subunidad p19 de la interleucina (IL)-23, bloquea la unión de IL-23 extracelular al receptor de IL-23 de la superficie celular, inhibiendo la señalización intracelular específica de IL-23, activación posterior y producción de citocinas.
Golimumab es un mAb anti-TNF-alfa totalmente humano que se une al TNF-alfa con alta afinidad, evita la unión a sus receptores, lo que inhibe la actividad biológica del TNF-alfa y da como resultado una producción o actividad limitada de citocinas inflamatorias, lo que proporciona una respuesta terapéutica. beneficio en varios trastornos inflamatorios crónicos, incluida la PsA.
Este estudio constará de una fase de detección (hasta 6 semanas), una fase doble ciego de las semanas 0 a la 24 que incluye la fase de tratamiento activo y la visita de eficacia primaria (semana 24) y una fase de seguimiento de seguridad de la semana 24 a la 24. Semana 36.
Las evaluaciones clave de seguridad incluirán eventos adversos (AA), pruebas de seguridad de laboratorio clínico (hematología y química), signos vitales, monitoreo de reacciones de hipersensibilidad y en el lugar de la inyección, y detección temprana de tuberculosis (TB) activa.
La duración total del estudio es de hasta 42 semanas.
Tipo de estudio
Intervencionista
Inscripción (Actual)
91
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Frederiksberg, Dinamarca, 2000
- Frederiksberg Hospital
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Glostrup Municipality, Dinamarca, 2600
- Rigshospitalet Glostrup
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Køge, Dinamarca, 4600
- Køge Sygehus Region Sjaelland
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Silkeborg, Dinamarca, 8600
- Silkeborg Hospital
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Vejle, Dinamarca, 7100
- Vejle Sygehus
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A Coruña, España, 15006
- Hosp Univ A Coruna
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Barcelona, España, 08916
- Hosp. Univ. Germans Trias I Pujol
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Bilbao, España, 48013
- Hosp. Univ. de Basurto
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Córdoba, España, 14004
- Hosp Reina Sofia
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Madrid, España, 28041
- Hosp. Univ. 12 de Octubre
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Sabadell, España, 08208
- Corporacio Sanitari Parc Tauli
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Santiago de Compostela, España, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, España, 41009
- Hosp. Virgen Macarena
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Seville, España, 41014
- Hosp. Ntra. Sra. de Valme
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Seville, España, 41010
- Hosp. Infanta Luisa
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Arizona
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Phoenix, Arizona, Estados Unidos, 85032
- Arizona Arthritis and Rheumatology Research PLLC
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Phoenix, Arizona, Estados Unidos, 85037
- Arizona Arthritis and Rheumatology Research PLLC 1
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Arkansas
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Searcy, Arkansas, Estados Unidos, 72143
- Unity Health-White County Medical Center
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Florida
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Avon Park, Florida, Estados Unidos, 33825
- HARAC Research Corp
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Bay Pines, Florida, Estados Unidos, 33744
- Bay Pines VA Healthcare System
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DeBary, Florida, Estados Unidos, 32713
- Omega Research Consultants
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Miami, Florida, Estados Unidos, 33136
- South Coast Research Center
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Ocoee, Florida, Estados Unidos, 34761
- Advanced Clinical Research of Orlando
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Ormond Beach, Florida, Estados Unidos, 32174
- Millennium Research
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Georgia
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Marietta, Georgia, Estados Unidos, 30060
- Atlanta Research Center for Rheumatology
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Michigan
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Lansing, Michigan, Estados Unidos, 48911
- Great Lakes Center of Rheumatology
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Missouri
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Springfield, Missouri, Estados Unidos, 65807
- Clinvest
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New York
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Brooklyn, New York, Estados Unidos, 11201
- NYU Langone Ambulatory Care Brooklyn Heights
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New York, New York, Estados Unidos, 10016
- NYU School of Medicine
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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The Bronx, New York, Estados Unidos, 10461
- Jacobi Medical Center
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Ohio
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Vandalia, Ohio, Estados Unidos, 45377
- STAT Research, Inc.
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Texas
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Plano, Texas, Estados Unidos, 75024
- Trinity Universal Research Associates, LLC
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Tomball, Texas, Estados Unidos, 77375
- DM Clinical Research
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Washington
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Seattle, Washington, Estados Unidos, 98122
- Swedish Medical Center
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Le Mans, Francia, 72037
- Centre Hospitalier Le Mans
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Toulouse, Francia, 31059
- Hopital Larrey CHU de Toulouse
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Tours, Francia, 37044
- CHU Trousseau - Service de Rhumatologie
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Budapest, Hungría, 1036
- Obudai Egeszsegugyi Centrum Kft
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Gyula, Hungría, 5700
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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Székesfehérvár, Hungría, 8000
- Complex Rendelo Med Zrt
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Veszprém, Hungría, 8200
- Vital Medical Center
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Cagliari, Italia, 09124
- Azienda Ospedaliero-Universitaria di Cagliari
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Milan, Italia, 20132
- Ospedale San Raffaele
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Milan, Italia, 20122
- Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
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Pavia, Italia, 27100
- IRCCS Policlinico San Matteo, Università degli studi di Pavi
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Reggio Emilia, Italia, 42123
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italia, 00168
- Policlinico Universitario Agostino Gemelli
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Roma, Italia, 00133
- A.O.U.Policlinico Tor Vergata
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Rome, Italia, 00128
- Università Campus Biomedico di Roma
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Torino, Italia, 10128
- AO Ordine Mauriziano
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Elblag, Polonia, 82-300
- Centrum Kliniczno Badawcze
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Lodz, Polonia, 90-242
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Nadarzyn, Polonia, 05-830
- NZOZ Lecznica MAK MED S C
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Poznan, Polonia, 61 113
- Centrum Medyczne
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Warsaw, Polonia, 00-874
- Medycyna Kliniczna
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Warsaw, Polonia, 03 291
- Centrum Medyczne AMED Targowek
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Wroclaw, Polonia, 51 685
- WroMedica I Bielicka A Strzalkowska s c
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Kemerovo, Rusia, 650000
- Kemerovo State Medical University
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Kemerovo, Rusia, 650070
- LLL Medical Center Revma-Med
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Korolyov, Rusia, 141060
- LLC Family Outpatient Clinic # 4
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Moscow, Rusia, 129110
- GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
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Orenburg, Rusia, 460000
- Orenburg State Medical Academy
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Rostov-on-Don, Rusia, 344007
- Rostov Regional Clinical Dermatovenerological Dispensary
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Ryazan, Rusia, 390046
- Ryazan Regional Clinical Dermatovenerological Dispensary
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Saint Petersburg, Rusia, 194156
- X7 Clinical Research Company Limited
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Smolensk, Rusia, 214025
- Smolensk regional hospital on Smolensk railway station
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Ufa, Rusia, 450005
- Republican Clinical Hospital - G.G. Kuvatov
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Yaroslavl, Rusia, 150007
- Clinical Hospital #3
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Malmö, Suecia, 205 02
- Skånes universitetssjukhus
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Solna, Suecia, 171 76
- Karolinska Universitetssjukhuset Solna
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Kharkiv, Ucrania, 61039
- State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
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Kharkiv, Ucrania, 61204
- Municipal Institution Regional hospital-center of emergency care and disasters medicine
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Kyiv, Ucrania, 03049
- Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
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Kyiv, Ucrania, 03680
- SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
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Kyiv, Ucrania, 03037
- Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
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Kyiv, Ucrania, 04107
- Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
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Poltava, Ucrania, 36011
- ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
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Ternopil, Ucrania, 46002
- Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
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Uzhhorod, Ucrania, 88000
- MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
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Vinnytsia, Ucrania, 21009
- Health Clinic Limited Liability Company
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Zaporizhzhya, Ucrania, 69600
- Medical Center LLC 'Modern Clinic'
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Tener un diagnóstico de artritis psoriásica (PsA) por más de o igual a (>=) 6 meses antes de la primera administración de la intervención del estudio y cumplir con los criterios de clasificación para PsA (CASPAR) en la selección
- Tener PsA activa según se define por tener al menos 3 articulaciones hinchadas y al menos 3 articulaciones sensibles en la selección y al inicio
- Tener al menos 1 de los siguientes subconjuntos de PsA: afectación de la articulación interfalángica distal, artritis poliarticular con ausencia de nódulos reumatoides, artritis mutilante, artritis periférica asimétrica o espondilitis con artritis periférica
- Tiene psoriasis en placas activa, con al menos una placa psoriásica de >=2 centímetros (cm) de diámetro o cambios en las uñas compatibles con psoriasis
- Tener una respuesta inadecuada (IR) a la terapia con factor de necrosis antitumoral alfa (anti-TNF-alfa), definida como la presencia de PsA activa a pesar del tratamiento con 1 o 2 agentes anti-TNF-alfa previos y los siguientes : a. Falta de beneficio de 1 o 2 terapias anti-TNF-alfa previas, según lo documentado en el historial del participante por el médico tratante, después de al menos 12 semanas de terapia con etanercept, adalimumab o certolizumab pegol, o al menos 14 semanas de infliximab , o cualquier biosimilar de estas 4 terapias. La falta de beneficio documentada puede incluir una mejora inadecuada en el recuento de articulaciones, la función física o la actividad de la enfermedad; b. La última dosis de la terapia anti-TNF-alfa debe haber ocurrido durante más de 5 semividas del fármaco antes de la administración de la primera intervención del estudio (período de lavado)
Criterio de exclusión:
- Tiene otras enfermedades inflamatorias que podrían confundir las evaluaciones del beneficio de la terapia con guselkumab y/o golimumab, incluidas, entre otras, artritis reumatoide (AR), espondilitis anquilosante (AS), espondiloartritis axial no radiográfica (nr AxSpA), lupus eritematoso sistémico o enfermedad de Lyme enfermedad
- Tiene intolerancia conocida o hipersensibilidad a cualquier medicamento biológico, o alergias conocidas o reacciones clínicamente significativas a proteínas murinas, quiméricas o humanas, anticuerpos monoclonales (mAb) o fragmentos de anticuerpos
- Ha recibido tratamiento previo con golimumab o guselkumab o tiene intolerancia documentada a la terapia anti-TNF-alfa previa en el historial del participante por el médico tratante
- Ha recibido más de 2 agentes anti-TNF-alfa anteriores (o biosimilares)
- Prueba de anticuerpos del virus de la inmunodeficiencia humana (VIH) positiva
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo 1: Guselkumab y Golimumab
Los participantes recibirán guselkumab y golimumab por vía subcutánea (SC).
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Guselkumab se administrará como una inyección SC.
Otros nombres:
Golimumab se administrará como una inyección SC.
Otros nombres:
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Comparador activo: Grupo 2: Guselkumab y Placebo
Los participantes recibirán guselkumab SC y placebo.
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Guselkumab se administrará como una inyección SC.
Otros nombres:
El placebo se administrará como una inyección SC.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24
Periodo de tiempo: Week 24
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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).
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Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 24
Periodo de tiempo: Week 24
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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).
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Week 24
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Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 16
Periodo de tiempo: Week 16
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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).
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Week 16
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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
Periodo de tiempo: Week 24
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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.
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Week 24
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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
Periodo de tiempo: Week 24
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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.
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Week 24
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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
Periodo de tiempo: Week 24
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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).
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Week 24
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
Periodo de tiempo: Baseline (Week 0), Week 24
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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.
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Baseline (Week 0), Week 24
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Percentage of Participants Who Had Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Periodo de tiempo: Week 24
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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.
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Week 24
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Percentage of Participants Who Achieved Resolution of Dactylitis Response at Week 24 Among the Participants With Dactylitis at Baseline
Periodo de tiempo: Week 24
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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.
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Week 24
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Change From Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24
Periodo de tiempo: Baseline (Week 0), Week 24
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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.
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Baseline (Week 0), Week 24
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Periodo de tiempo: From Week 0 up to Week 36
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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.
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From Week 0 up to Week 36
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Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: From Week 0 up to Week 36
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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.
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From Week 0 up to Week 36
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Percentage of Participants With Reasonably Related Adverse Events (AEs)
Periodo de tiempo: From Week 0 up to Week 36
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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.
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From Week 0 up to Week 36
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Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Periodo de tiempo: From Week 0 to Week 20
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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.
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From Week 0 to Week 20
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Percentage of Participants With Infections
Periodo de tiempo: From Week 0 up to Week 36
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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.
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From Week 0 up to Week 36
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Percentage of Participants With Injection-site Reactions
Periodo de tiempo: From Week 0 up to Week 36
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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.
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From Week 0 up to Week 36
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Group 1: Guselkumab Plus Golimumab - Serum Concentration of Golimumab
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, 24, and 36
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Serum concentration of golimumab was reported.
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Weeks 0, 4, 8, 12, 16, 20, 24, and 36
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Serum Concentration of Guselkumab
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20, 24, and 36
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Serum concentration of guselkumab was reported.
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Weeks 0, 4, 8, 12, 16, 20, 24, and 36
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Percentage of Participants With Anti-Guselkumab Antibodies
Periodo de tiempo: From Week 0 up to Week 36
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Percentage of participants with anti-guselkumab antibodies was reported.
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From Week 0 up to Week 36
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Percentage of Participants With Anti-Golimumab Antibodies
Periodo de tiempo: From Week 0 up to Week 36
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Percentage of participants with anti-golimumab antibodies were reported.
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From Week 0 up to Week 36
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de octubre de 2021
Finalización primaria (Actual)
14 de mayo de 2024
Finalización del estudio (Actual)
6 de agosto de 2024
Fechas de registro del estudio
Enviado por primera vez
6 de septiembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
28 de septiembre de 2021
Publicado por primera vez (Actual)
8 de octubre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades de la columna
- Espondiloartropatías
- Enfermedades De La Piel Papuloescamosa
- Enfermedades de la piel
- Espondiloartritis
- Espondilitis
- Soriasis
- Enfermedades de la piel y del tejido conectivo
- Artritis, Psoriásica
- Inhibidores del factor de necrosis tumoral
- Agentes inmunosupresores
- Factores inmunológicos
- Efectos fisiológicos de las drogas
- Agentes antiinflamatorios
- guselkumab
- golimumab
Otros números de identificación del estudio
- CR109054
- 2021-002012-31 (Número EudraCT)
- CNTO1959PSA2003 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
La política de intercambio de datos de Janssen Pharmaceutical Companies of Johnson & Johnson está disponible en www.janssen.com/clinical-trials/transparency.
Como se indica en este sitio, las solicitudes de acceso a los datos del estudio se pueden enviar a través del sitio del proyecto Yale Open Data Access (YODA) en yoda.yale.edu
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .