Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

En studie av Guselkumab och Golimumab kombinationsterapi hos deltagare med aktiv psoriasisartrit (AFFINITY)

25 juni 2026 uppdaterad av: Janssen Research & Development, LLC

En fas 2a, multicenter, randomiserad, dubbelblind studie som utvärderar effektiviteten och säkerheten av subkutant administrerad Guselkumab och Golimumab kombinationsterapi hos deltagare med aktiv psoriasisartrit

Syftet med denna studie är att utvärdera effekten av kombinationsbehandling med guselkumab plus golimumab hos deltagare med aktiv psoriasisartrit (PsA) och otillräckligt svar (IR) på tidigare anti-tumörnekrosfaktor-alfa (anti-TNF-alfa)-terapier genom att utvärdera kliniskt svar jämfört med guselkumab monoterapi.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PsA är en kronisk inflammatorisk mångfacetterad sjukdom som påverkar de perifera och axiella lederna, mjuka vävnaderna och huden. Guselkumab är en helt human monoklonal antikropp (mAb) riktad mot p19-subenheten av interleukin (IL)-23, blockerar bindningen av extracellulär IL-23 till cellytans IL-23-receptor, hämmar IL-23-specifik intracellulär signalering, efterföljande aktivering och cytokinproduktion. Golimumab är ett fullt humant anti-TNF-alfa-mAb som binder till TNF-alfa med hög affinitet, förhindrar bindning till dess receptorer, och därigenom hämmar den biologiska aktiviteten av TNF-alfa och resulterar i begränsad produktion eller aktivitet av inflammatoriska cytokiner, vilket ger terapeutisk fördelar vid olika kroniska inflammatoriska störningar, inklusive PsA. Denna studie kommer att bestå av en screeningfas (upp till 6 veckor), dubbelblind fas från vecka 0 till 24 som inkluderar den aktiva behandlingsfasen och det primära effektivitetsbesöket (vecka 24), och säkerhetsuppföljningsfas från vecka 24 till Vecka 36. Nyckelsäkerhetsbedömningar kommer att omfatta biverkningar (AE), kliniska laboratorietester (hematologi och kemi), vitala tecken, övervakning av injektionsstället och överkänslighetsreaktioner och tidig upptäckt av aktiv tuberkulos (TB). Studiens totala varaktighet är upp till 42 veckor.

Studietyp

Interventionell

Inskrivning (Faktisk)

91

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • 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
  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85032
        • Arizona Arthritis and Rheumatology Research PLLC
      • Phoenix, Arizona, Förenta staterna, 85037
        • Arizona Arthritis and Rheumatology Research PLLC 1
    • Arkansas
      • Searcy, Arkansas, Förenta staterna, 72143
        • Unity Health-White County Medical Center
    • Florida
      • Avon Park, Florida, Förenta staterna, 33825
        • HARAC Research Corp
      • Bay Pines, Florida, Förenta staterna, 33744
        • Bay Pines VA Healthcare System
      • DeBary, Florida, Förenta staterna, 32713
        • Omega Research Consultants
      • Miami, Florida, Förenta staterna, 33136
        • South Coast Research Center
      • Ocoee, Florida, Förenta staterna, 34761
        • Advanced Clinical Research of Orlando
      • Ormond Beach, Florida, Förenta staterna, 32174
        • Millennium Research
    • Georgia
      • Marietta, Georgia, Förenta staterna, 30060
        • Atlanta Research Center for Rheumatology
    • Michigan
      • Lansing, Michigan, Förenta staterna, 48911
        • Great Lakes Center of Rheumatology
    • Missouri
      • Springfield, Missouri, Förenta staterna, 65807
        • Clinvest
    • New York
      • Brooklyn, New York, Förenta staterna, 11201
        • NYU Langone Ambulatory Care Brooklyn Heights
      • New York, New York, Förenta staterna, 10016
        • NYU School of Medicine
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester
      • The Bronx, New York, Förenta staterna, 10461
        • Jacobi Medical Center
    • Ohio
      • Vandalia, Ohio, Förenta staterna, 45377
        • STAT Research, Inc.
    • Texas
      • Plano, Texas, Förenta staterna, 75024
        • Trinity Universal Research Associates, LLC
      • Tomball, Texas, Förenta staterna, 77375
        • DM Clinical Research
    • Washington
      • Seattle, Washington, Förenta staterna, 98122
        • Swedish Medical Center
  • 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
  • Ryssland
      • Kemerovo, Ryssland, 650000
        • Kemerovo State Medical University
      • Kemerovo, Ryssland, 650070
        • LLL Medical Center Revma-Med
      • Korolyov, Ryssland, 141060
        • LLC Family Outpatient Clinic # 4
      • Moscow, Ryssland, 129110
        • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
      • Orenburg, Ryssland, 460000
        • Orenburg State Medical Academy
      • Rostov-on-Don, Ryssland, 344007
        • Rostov Regional Clinical Dermatovenerological Dispensary
      • Ryazan, Ryssland, 390046
        • Ryazan Regional Clinical Dermatovenerological Dispensary
      • Saint Petersburg, Ryssland, 194156
        • X7 Clinical Research Company Limited
      • Smolensk, Ryssland, 214025
        • Smolensk regional hospital on Smolensk railway station
      • Ufa, Ryssland, 450005
        • Republican Clinical Hospital - G.G. Kuvatov
      • Yaroslavl, Ryssland, 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
  • 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'
  • Ungern
      • Budapest, Ungern, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Gyula, Ungern, 5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Székesfehérvár, Ungern, 8000
        • Complex Rendelo Med Zrt
      • Veszprém, Ungern, 8200
        • Vital Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Ha en diagnos av psoriasisartrit (PsA) i mer än eller lika med (>=) 6 månader före den första administreringen av studieintervention och uppfylla klassificeringskriterierna för PsA (CASPAR) kriterier vid screening
  • Ha aktiv PsA enligt definition genom att ha minst 3 svullna leder och minst 3 ömma leder vid screening och vid baslinjen
  • Ha minst 1 av följande PsA-undergrupper: distal interfalangeal ledinblandning, polyartikulär artrit med frånvaro av reumatoida knölar, artrit mutilans, asymmetrisk perifer artrit eller spondylit med perifer artrit
  • Har aktiv plackpsoriasis, med minst en psoriasisplack med diameter >=2 centimeter (cm) eller nagelförändringar som överensstämmer med psoriasis
  • Har ett otillräckligt svar (IR) på anti-tumörnekrosfaktor-alfa (anti-TNF-alfa)-terapi, definierat som närvaro av aktivt PsA trots behandling med antingen 1 eller 2 tidigare anti-TNF-alfa-medel och följande : a. Brist på nytta av antingen 1 eller 2 tidigare anti-TNF-alfa-terapier, som dokumenterats i deltagarhistorien av den behandlande läkaren, efter minst 12 veckors behandling med etanercept, adalimumab eller certolizumab pegol, eller minst 14 veckors infliximab , eller någon bioliknande av dessa 4 terapier. Dokumenterad brist på nytta kan inkludera otillräcklig förbättring av ledvärden, fysisk funktion eller sjukdomsaktivitet; b. Den sista dosen av anti-TNF-alfa-terapi måste ha inträffat mer än 5 halveringstider av läkemedlet före första studieinterventionsadministrering (uttvättningsperiod)

Exklusions kriterier:

  • Har andra inflammatoriska sjukdomar som kan förvirra utvärderingarna av nyttan av behandling med guselkumab och/eller golimumab, inklusive men inte begränsat till reumatoid artrit (RA), ankyloserande spondylit (AS), icke-radiografisk axiell spondyloartrit (nr AxSpA), systemisk lupus erythematosus eller ly. sjukdom
  • Har känd intolerans eller överkänslighet mot någon biologisk medicin, eller kända allergier eller kliniskt signifikanta reaktioner på murina, chimära eller humana proteiner, monoklonala antikroppar (mAb) eller antikroppsfragment
  • Har tidigare fått behandling med golimumab eller guselkumab eller har dokumenterat intolerans mot tidigare anti-TNF-alfabehandling i deltagarhistorien av den behandlande läkaren
  • Har fått mer än 2 tidigare anti-TNF-alfa-medel (eller biosimilarer)
  • Positivt antikroppstest för humant immunbristvirus (HIV).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Grupp 1: Guselkumab och Golimumab
Deltagarna kommer att få subkutan (SC) guselkumab och golimumab.
Läkemedel: Guselkumab
Guselkumab kommer att administreras som en subkutan injektion.
Andra namn:
  • CNTO1959
  • TREMFYA
Läkemedel: Golimumab
Golimumab kommer att administreras som en subkutan injektion.
Andra namn:
  • SIMPONI
  • CNTO148
Aktiv komparator: Grupp 2: Guselkumab och Placebo
Deltagarna kommer att få SC guselkumab och placebo.
Läkemedel: Guselkumab
Guselkumab kommer att administreras som en subkutan injektion.
Andra namn:
  • CNTO1959
  • TREMFYA
Läkemedel: Placebo
Placebo kommer att administreras som en subkutan injektion.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Research & Development, LLC

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 oktober 2021

Primärt slutförande (Faktisk)

14 maj 2024

Avslutad studie (Faktisk)

6 augusti 2024

Studieregistreringsdatum

Först inskickad

6 september 2021

Först inskickad som uppfyllde QC-kriterierna

28 september 2021

Första postat (Faktisk)

8 oktober 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Datadelningspolicyn för Janssen Pharmaceutical Companies of Johnson & Johnson finns på www.janssen.com/clinical-trials/transparency. Som nämnts på den här webbplatsen kan förfrågningar om åtkomst till studiedata skickas via Yale Open Data Access (YODA) projektwebbplats på yoda.yale.edu

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera