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En studie av Guselkumab og Golimumab kombinasjonsterapi hos deltakere med aktiv psoriasisartritt (AFFINITY)

25. juni 2026 oppdatert av: Janssen Research & Development, LLC

En fase 2a, multisenter, randomisert, dobbeltblind studie som evaluerer effektiviteten og sikkerheten til subkutant administrert Guselkumab og Golimumab kombinasjonsterapi hos deltakere med aktiv psoriasisartritt

Hensikten med denne studien er å evaluere effekten av guselkumab pluss golimumab kombinasjonsbehandling hos deltakere med aktiv psoriasisartritt (PsA) og utilstrekkelig respons (IR) på tidligere anti-tumor nekrose faktor-alfa (anti-TNF-alfa) behandlinger ved å vurdere klinisk respons sammenlignet med guselkumab monoterapi.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PsA er en kronisk inflammatorisk mangefasettert sykdom som påvirker perifere og aksiale ledd, bløtvev og hud. Guselkumab er et fullstendig humant monoklonalt antistoff (mAb) rettet mot p19-underenheten til interleukin (IL)-23, blokkerer bindingen av ekstracellulært IL-23 til celleoverflaten IL-23-reseptoren, hemmer IL-23-spesifikk intracellulær signalering, påfølgende aktivering og cytokinproduksjon. Golimumab er et fullt humant anti-TNF-alfa mAb som binder seg til TNF-alfa med høy affinitet, forhindrer binding til reseptorene, og derved hemmer den biologiske aktiviteten til TNF-alfa og resulterer i begrenset produksjon eller aktivitet av inflammatoriske cytokiner, og gir dermed terapeutisk fordel ved ulike kroniske inflammatoriske lidelser, inkludert PsA. Denne studien vil bestå av en screeningsfase (opptil 6 uker), dobbeltblind fase fra uke 0 til 24 som inkluderer den aktive behandlingsfasen og det primære effektbesøket (uke 24), og sikkerhetsoppfølgingsfasen fra uke 24 til Uke 36. Viktige sikkerhetsvurderinger vil inkludere uønskede hendelser (AE), kliniske laboratorietester (hematologi og kjemi), vitale tegn, overvåking for injeksjonssted og overfølsomhetsreaksjoner, og tidlig påvisning av aktiv tuberkulose (TB). Den totale varigheten av studien er opptil 42 uker.

Studietype

Intervensjonell

Registrering (Faktiske)

91

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85032
        • Arizona Arthritis and Rheumatology Research PLLC
      • Phoenix, Arizona, Forente stater, 85037
        • Arizona Arthritis and Rheumatology Research PLLC 1
    • Arkansas
      • Searcy, Arkansas, Forente stater, 72143
        • Unity Health-White County Medical Center
    • Florida
      • Avon Park, Florida, Forente stater, 33825
        • HARAC Research Corp
      • Bay Pines, Florida, Forente stater, 33744
        • Bay Pines VA Healthcare System
      • DeBary, Florida, Forente stater, 32713
        • Omega Research Consultants
      • Miami, Florida, Forente stater, 33136
        • South Coast Research Center
      • Ocoee, Florida, Forente stater, 34761
        • Advanced Clinical Research of Orlando
      • Ormond Beach, Florida, Forente stater, 32174
        • Millennium Research
    • Georgia
      • Marietta, Georgia, Forente stater, 30060
        • Atlanta Research Center for Rheumatology
    • Michigan
      • Lansing, Michigan, Forente stater, 48911
        • Great Lakes Center of Rheumatology
    • Missouri
      • Springfield, Missouri, Forente stater, 65807
        • Clinvest
    • New York
      • Brooklyn, New York, Forente stater, 11201
        • NYU Langone Ambulatory Care Brooklyn Heights
      • New York, New York, Forente stater, 10016
        • NYU School of Medicine
      • Rochester, New York, Forente stater, 14642
        • University of Rochester
      • The Bronx, New York, Forente stater, 10461
        • Jacobi Medical Center
    • Ohio
      • Vandalia, Ohio, Forente stater, 45377
        • STAT Research, Inc.
    • Texas
      • Plano, Texas, Forente stater, 75024
        • Trinity Universal Research Associates, LLC
      • Tomball, Texas, Forente stater, 77375
        • DM Clinical Research
    • Washington
      • Seattle, Washington, Forente stater, 98122
        • Swedish Medical Center
  • Frankrike
      • Le Mans, Frankrike, 72037
        • Centre Hospitalier Le Mans
      • Toulouse, Frankrike, 31059
        • Hopital Larrey CHU de Toulouse
      • Tours, Frankrike, 37044
        • CHU Trousseau - Service de Rhumatologie
  • Italia
      • Cagliari, Italia, 09124
        • Azienda Ospedaliero-Universitaria di Cagliari
      • Milan, Italia, 20132
        • Ospedale San Raffaele
      • Milan, Italia, 20122
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
      • Pavia, Italia, 27100
        • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
      • Reggio Emilia, Italia, 42123
        • Arcispedale Santa Maria Nuova - IRCCS
      • Roma, Italia, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italia, 00133
        • A.O.U.Policlinico Tor Vergata
      • Rome, Italia, 00128
        • Università Campus Biomedico di Roma
      • Torino, Italia, 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
  • Russland
      • Kemerovo, Russland, 650000
        • Kemerovo State Medical University
      • Kemerovo, Russland, 650070
        • LLL Medical Center Revma-Med
      • Korolyov, Russland, 141060
        • LLC Family Outpatient Clinic # 4
      • Moscow, Russland, 129110
        • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
      • Orenburg, Russland, 460000
        • Orenburg State Medical Academy
      • Rostov-on-Don, Russland, 344007
        • Rostov Regional Clinical Dermatovenerological Dispensary
      • Ryazan, Russland, 390046
        • Ryazan Regional Clinical Dermatovenerological Dispensary
      • Saint Petersburg, Russland, 194156
        • X7 Clinical Research Company Limited
      • Smolensk, Russland, 214025
        • Smolensk regional hospital on Smolensk railway station
      • Ufa, Russland, 450005
        • Republican Clinical Hospital - G.G. Kuvatov
      • Yaroslavl, Russland, 150007
        • Clinical Hospital #3
  • Spania
      • A Coruña, Spania, 15006
        • Hosp Univ A Coruna
      • Barcelona, Spania, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Bilbao, Spania, 48013
        • Hosp. Univ. de Basurto
      • Córdoba, Spania, 14004
        • Hosp Reina Sofia
      • Madrid, Spania, 28041
        • Hosp. Univ. 12 de Octubre
      • Sabadell, Spania, 08208
        • Corporacio Sanitari Parc Tauli
      • Santiago de Compostela, Spania, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spania, 41009
        • Hosp. Virgen Macarena
      • Seville, Spania, 41014
        • Hosp. Ntra. Sra. de Valme
      • Seville, Spania, 41010
        • Hosp. Infanta Luisa
  • Sverige
      • Malmö, Sverige, 205 02
        • Skånes universitetssjukhus
      • Solna, Sverige, 171 76
        • Karolinska Universitetssjukhuset Solna
  • Ukraina
      • Kharkiv, Ukraina, 61039
        • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
      • Kharkiv, Ukraina, 61204
        • Municipal Institution Regional hospital-center of emergency care and disasters medicine
      • Kyiv, Ukraina, 03049
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv, Ukraina, 03680
        • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
      • Kyiv, Ukraina, 03037
        • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
      • Kyiv, Ukraina, 04107
        • Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
      • Poltava, Ukraina, 36011
        • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
      • Ternopil, Ukraina, 46002
        • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
      • Uzhhorod, Ukraina, 88000
        • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
      • Vinnytsia, Ukraina, 21009
        • Health Clinic Limited Liability Company
      • Zaporizhzhya, Ukraina, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Ha en diagnose av psoriasisartritt (PsA) i mer enn eller lik (>=) 6 måneder før første administrasjon av studieintervensjon og oppfyller klassifiseringskriteriene for PsA (CASPAR) kriterier ved screening
  • Ha aktiv PsA som definert ved å ha minst 3 hovne ledd og minst 3 ømme ledd ved screening og ved baseline
  • Ha minst 1 av følgende PsA-undergrupper: distal interfalangeal leddinvolvering, polyartikulær artritt med fravær av revmatoide knuter, artritt mutilans, asymmetrisk perifer artritt eller spondylitt med perifer artritt
  • Har aktiv plakkpsoriasis, med minst ett psoriasisplakk på >=2 centimeter (cm) i diameter eller negleforandringer i samsvar med psoriasis
  • Har en utilstrekkelig respons (IR) på anti-tumor nekrose faktor-alfa (anti-TNF-alfa)-terapi, definert som tilstedeværelse av aktiv PsA til tross for behandling med enten 1 eller 2 tidligere anti-TNF-alfa-midler og følgende : a. Mangel på fordel for enten 1 eller 2 tidligere anti-TNF-alfa-terapier, som dokumentert i deltakerhistorien av behandlende lege, etter minst 12 uker med etanercept-, adalimumab- eller certolizumab pegol-behandling, eller minst 14 uker med infliksimab , eller en hvilken som helst biosimilar av disse 4 terapiene. Dokumentert mangel på nytte kan omfatte utilstrekkelig forbedring i leddtall, fysisk funksjon eller sykdomsaktivitet; b. Den siste dosen av anti-TNF-alfa-terapi må ha skjedd mer enn 5 halveringstider av legemidlet før første studieintervensjonsadministrasjon (utvaskingsperiode)

Ekskluderingskriterier:

  • Har andre inflammatoriske sykdommer som kan forvirre vurderingene av fordelene ved behandling med guselkumab og/eller golimumab, inkludert men ikke begrenset til revmatoid artritt (RA), ankyloserende spondylitt (AS), ikke-radiografisk aksial spondyloartritt (nr AxSpA), systemisk lupus erythematosus eller ly. sykdom
  • Har kjent intoleranse eller overfølsomhet overfor noen biologisk medisin, eller kjente allergier eller klinisk signifikante reaksjoner på murine, kimære eller humane proteiner, monoklonale antistoffer (mAb) eller antistofffragmenter
  • Har mottatt tidligere behandling med golimumab eller guselkumab eller har dokumentert intoleranse mot tidligere anti-TNF-alfa-terapi i deltakerhistorien av behandlende lege
  • Har mottatt mer enn 2 tidligere anti-TNF-alfa-midler (eller biosimilarer)
  • Positiv antistofftest for humant immunsviktvirus (HIV).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gruppe 1: Guselkumab og Golimumab
Deltakerne vil motta subkutan (SC) guselkumab og golimumab.
Legemiddel: Guselkumab
Guselkumab vil bli administrert som en subkutan injeksjon.
Andre navn:
  • CNTO1959
  • TREMFYA
Legemiddel: Golimumab
Golimumab vil bli administrert som en subkutan injeksjon.
Andre navn:
  • SIMPONI
  • CNTO148
Aktiv komparator: Gruppe 2: Guselkumab og Placebo
Deltakerne vil motta SC guselkumab og placebo.
Legemiddel: Guselkumab
Guselkumab vil bli administrert som en subkutan injeksjon.
Andre navn:
  • CNTO1959
  • TREMFYA
Legemiddel: Placebo
Placebo vil bli administrert som en SC-injeksjon.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. oktober 2021

Primær fullføring (Faktiske)

14. mai 2024

Studiet fullført (Faktiske)

6. august 2024

Datoer for studieregistrering

Først innsendt

6. september 2021

Først innsendt som oppfylte QC-kriteriene

28. september 2021

Først lagt ut (Faktiske)

8. oktober 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Datadelingspolicyen til Janssen Pharmaceutical Companies of Johnson & Johnson er tilgjengelig på www.janssen.com/clinical-trials/transparency. Som nevnt på dette nettstedet, kan forespørsler om tilgang til studiedata sendes inn via Yale Open Data Access (YODA) prosjektnettsted på yoda.yale.edu

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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