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En undersøgelse af Guselkumab og Golimumab kombinationsterapi hos deltagere med aktiv psoriasisgigt (AFFINITY)

25. juni 2026 opdateret af: Janssen Research & Development, LLC

En fase 2a, multicenter, randomiseret, dobbeltblind undersøgelse, der evaluerer effektiviteten og sikkerheden af ​​subkutant administreret Guselkumab og Golimumab kombinationsterapi hos deltagere med aktiv psoriasisgigt

Formålet med denne undersøgelse er at evaluere effektiviteten af ​​guselkumab plus golimumab kombinationsbehandling hos deltagere med aktiv psoriasisgigt (PsA) og utilstrækkelig respons (IR) på tidligere anti-tumor nekrose faktor-alfa (anti-TNF-alfa) behandlinger ved at vurdere klinisk respons sammenlignet med guselkumab monoterapi.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PsA er en kronisk inflammatorisk mangefacetteret sygdom, der påvirker de perifere og aksiale led, blødt væv og hud. Guselkumab er et fuldt humant monoklonalt antistof (mAb) rettet mod p19-underenheden af ​​interleukin (IL)-23, blokerer bindingen af ​​ekstracellulær IL-23 til celleoverflade-IL-23-receptoren, hæmmer IL-23-specifik intracellulær signalering, efterfølgende aktivering og cytokinproduktion. Golimumab er et fuldt humant anti-TNF-alfa-mAb, der binder til TNF-alfa med høj affinitet, forhindrer binding til dets receptorer, og derved hæmmer den biologiske aktivitet af TNF-alfa og resulterer i begrænset produktion eller aktivitet af inflammatoriske cytokiner, hvilket giver terapeutisk gavn ved forskellige kroniske inflammatoriske lidelser, herunder PsA. Denne undersøgelse vil bestå af en screeningsfase (op til 6 uger), dobbeltblindet fase fra uge 0 til 24, som omfatter den aktive behandlingsfase og det primære effektivitetsbesøg (uge 24), og sikkerhedsopfølgningsfase fra uge 24 til Uge 36. Nøgle sikkerhedsvurderinger vil omfatte uønskede hændelser (AE'er), kliniske laboratoriesikkerhedstests (hæmatologi og kemi), vitale tegn, overvågning for injektionsstedet og overfølsomhedsreaktioner og tidlig påvisning af aktiv tuberkulose (TB). Den samlede varighed af undersøgelsen er op til 42 uger.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

91

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Har en diagnose af psoriasisgigt (PsA) i mere end eller lig med (>=) 6 måneder før den første administration af undersøgelsesintervention og opfylder klassifikationskriterier for PsA (CASPAR) kriterier ved screening
  • Har aktiv PsA som defineret ved at have mindst 3 hævede led og mindst 3 ømme led ved screening og ved baseline
  • Har mindst 1 af følgende PsA-undergrupper: distal interfalangeal led involvering, polyartikulær arthritis med fravær af leddegigt, arthritis mutilans, asymmetrisk perifer arthritis eller spondylitis med perifer arthritis
  • Har aktiv plakpsoriasis med mindst én psoriasisplak på >=2 centimeter (cm) i diameter eller negleforandringer i overensstemmelse med psoriasis
  • Har en utilstrækkelig respons (IR) på anti-tumor nekrose faktor-alfa (anti-TNF-alfa) terapi, defineret som tilstedeværelse af aktivt PsA på trods af behandling med enten 1 eller 2 tidligere anti-TNF-alfa-midler og følgende : a. Manglende fordel ved enten 1 eller 2 tidligere anti-TNF-alfa-terapier, som dokumenteret i deltagerhistorien af ​​den behandlende læge, efter mindst 12 ugers behandling med etanercept, adalimumab eller certolizumab pegol eller mindst 14 ugers infliximab , eller en hvilken som helst biosimilær af disse 4 behandlinger. Dokumenteret mangel på fordele kan omfatte utilstrækkelig forbedring af ledtal, fysisk funktion eller sygdomsaktivitet; b. Den sidste dosis af anti-TNF-alfa-terapi skal have fundet sted mere end 5 halveringstider af lægemidlet før indgivelse af første undersøgelsesintervention (udvaskningsperiode)

Ekskluderingskriterier:

  • Har andre inflammatoriske sygdomme, der kan forvirre vurderingen af ​​fordelene ved behandling med guselkumab og/eller golimumab, herunder men ikke begrænset til reumatoid arthritis (RA), ankyloserende spondylitis (AS), ikke-radiografisk aksial spondyloarthritis (nr AxSpA), systemisk lupus erythematosus eller ly. sygdom
  • Har kendt intolerance eller overfølsomhed over for enhver biologisk medicin eller kendte allergier eller klinisk signifikante reaktioner på murine, kimære eller humane proteiner, monoklonale antistoffer (mAb) eller antistoffragmenter
  • Har modtaget tidligere behandling med golimumab eller guselkumab eller har dokumenteret intolerance over for tidligere anti-TNF-alfa-terapi i deltagerhistorien af ​​den behandlende læge
  • Har modtaget mere end 2 tidligere anti-TNF-alfa-midler (eller biosimilarer)
  • Positiv human immundefekt virus (HIV) antistoftest

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gruppe 1: Guselkumab og Golimumab
Deltagerne vil modtage subkutan (SC) guselkumab og golimumab.
Medicin: Guselkumab
Guselkumab vil blive administreret som en subkutan injektion.
Andre navne:
  • CNTO1959
  • TREMFYA
Medicin: Golimumab
Golimumab vil blive administreret som en subkutan injektion.
Andre navne:
  • SIMPONI
  • CNTO148
Aktiv komparator: Gruppe 2: Guselkumab og Placebo
Deltagerne vil modtage SC guselkumab og placebo.
Medicin: Guselkumab
Guselkumab vil blive administreret som en subkutan injektion.
Andre navne:
  • CNTO1959
  • TREMFYA
Medicin: Placebo
Placebo vil blive indgivet som en subkutan injektion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From Week 0 up to Week 36
Percentage of participants with anti-golimumab antibodies were reported.
From Week 0 up to Week 36

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. oktober 2021

Primær færdiggørelse (Faktiske)

14. maj 2024

Studieafslutning (Faktiske)

6. august 2024

Datoer for studieregistrering

Først indsendt

6. september 2021

Først indsendt, der opfyldte QC-kriterier

28. september 2021

Først opslået (Faktiske)

8. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR109054
  • 2021-002012-31 (EudraCT nummer)
  • CNTO1959PSA2003 (Anden identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Datadelingspolitikken for Janssen Pharmaceutical Companies of Johnson & Johnson er tilgængelig på www.janssen.com/clinical-trials/transparency. Som nævnt på dette websted kan anmodninger om adgang til undersøgelsesdataene indsendes gennem Yale Open Data Access (YODA) projektwebsted på yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner