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En undersøgelse for at observere real-world evidens for Guselkumab-behandling hos deltagere med ulcerøs colitis og Crohns sygdom i Storbritannien (UK) (GUSTO-UK)

2. november 2026 opdateret af: Janssen-Cilag Ltd.

Reel Verdens Observation af Guselkumab Behandling hos Patienter med Colitis Ulcerosa og Crohns Sygdom - en Undersøgelse af Behandlingsresultater i Storbritannien

The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
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Kontakter og lokationer

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

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Det Forenede Kongerige
      • Harrow, Det Forenede Kongerige, HA1 3UJ
        • Rekruttering
        • London North West University Healthcare NHS Trust

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.

Beskrivelse

Inclusion Criteria:

  • Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician)
  • Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records
  • Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion Criteria:

  • Contraindicated to guselkumab per the label
  • Is currently enrolled in an interventional clinical study
  • Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included
  • Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and /or small molecules)
  • Is unable to provide informed consent

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)

Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Tidsramme: Up to Week 96

HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical remission for CD is defined as the HBI score less than or equal to (<=) 4.
Up to Week 96
Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
Tidsramme: Up to Week 96

Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical remission for UC is defined as the PMS score <=2 and a rectal bleeding subscore of 0.
Up to Week 96
Number of Participants Achieving Clinical Response for CD as Measured by HBI
Tidsramme: Up to Week 96

HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical response for CD is defined as the HBI score less than or equal to (<=) 4 or a decrease by greater than or equal to (>=) 3.
Up to Week 96
Number of Participants Achieving Clinical Response for UC as Measured by PMS
Tidsramme: Up to Week 96

Mayo scoring system is used to assess disease severity and treatment effectiveness. Clinical response for UC is defined as the PMS <4 or >=30 percent (%) reduction of baseline PMS.
Up to Week 96
Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI
Tidsramme: Up to Week 96

Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and HBI score <=4. HBI score is used to assess disease severity and treatment effectiveness.
Up to Week 96
Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS
Tidsramme: Up to Week 96

Corticosteroid-free clinical remission for UC is defined as no use of steroids for at least 30 days and PMS <2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Up to Week 96
Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI
Tidsramme: Up to Week 96

Corticosteroid-free clinical response for CD is defined as no use of steroids for at least 30 days and a reduction in HBI score by >=3 points from baseline or achieving HBI score <=4. HBI score is used to assess disease severity and treatment effectiveness.
Up to Week 96
Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS
Tidsramme: Up to Week 96

Corticosteroid-free clinical response for UC is defined as no use of steroids for at least 30 days and PMS <4 or >=30% reduction from baseline. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Up to Week 96
Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI
Tidsramme: Up to Week 96

Participants with corticosteroid-free remission by PRO-2 will be assessed. An abdominal pain (AP) score <=1 and a mean stool frequency (SF) score <=3 and no worsening of AP or SF compared with baseline and no use of corticosteroids for at least 30 days will be defined as a PRO-2 corticosteroid-free remission.
Up to Week 96
Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS
Tidsramme: Up to Week 96

Participants with corticosteroid-free remission by PRO-2 will be assessed. An SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding score of 0 with no use of corticosteroids for at least 30 days will be defined as a corticosteroid-free PRO-2 remission.
Up to Week 96

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for UC
Tidsramme: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12

Participants with early responses to guselkumab using PRO-2 components will be assessed and reported via patient diary card.
Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using PRO-2 Components for CD
Tidsramme: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12

Participants with early responses to guselkumab using PRO-2 components will be assessed and reported via patient diary card.
Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency
Tidsramme: Baseline (at Week 0), Weeks 1, 2, 4, 8, 12

Participants with early responses to guselkumab using bowel urgency will be assessed and reported via patient diary card. Change in bowel urgency for participants will be asked, that is, how severe were the bowel urgency.
Baseline (at Week 0), Weeks 1, 2, 4, 8, 12
Time to Guselkumab Persistence
Tidsramme: Up to Week 96

Persistence with guselkumab will be measured through time to discontinuation (defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion).
Up to Week 96
Characteristics of Participants Receiving Guselkumab Treatment: Age
Tidsramme: At Baseline

Characteristics of participants (age) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex
Tidsramme: At Baseline

Characteristics of participants (sex) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD Medication Use, Smoking Status and History, History of UC and History of CD
Tidsramme: At Baseline

Characteristics of participants (previous IBD medication use, smoking status and history, history of UC and history of CD) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height
Tidsramme: At Baseline

Characteristics of participants (height) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight
Tidsramme: At Baseline

Characteristics of participants (weight) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity
Tidsramme: At Baseline

Characteristics of participants (disease severity at index) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis
Tidsramme: At Baseline

Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration
Tidsramme: At Baseline

Characteristics of participants (disease duration) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses
Tidsramme: At Baseline

Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will be reported.
At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries
Tidsramme: At Baseline

Characteristics of participants (IBD-related surgeries) receiving guselkumab treatment will be reported.
At Baseline
Number of Participants with Adverse Events (AEs)
Tidsramme: Up to Week 96

An adverse event is any untoward medical occurrence in a patient administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Up to Week 96
Change in C-reactive protein (CRP) Levels
Tidsramme: Baseline up to Week 96

Change in CRP levels since guselkumab initiation will be reported.
Baseline up to Week 96
Number of Participants with CRP Normalization
Tidsramme: At Week 0, 4, 12, 48 and 96

Participants with CRP normalization (among participants with CRP elevated at baseline) since guselkumab initiation will be reported.
At Week 0, 4, 12, 48 and 96
Change in Faecal Calprotectin (Fcal) Levels
Tidsramme: Baseline up to Week 96

Change in Fcal levels since guselkumab initiation will be reported.
Baseline up to Week 96
Number of Participants with Fcal Normalization
Tidsramme: At Week 0, 4, 12, 48 and 96

Participants with Fcal normalization (among participants with faecal calprotectin [Fcal] elevated at baseline) since guselkumab initiation will be reported.
At Week 0, 4, 12, 48 and 96
Change in Albumin Levels
Tidsramme: At Week 0, 4, 12, 48 and 96

Change in albumin levels to assess anaemia and nutritional status will be reported.
At Week 0, 4, 12, 48 and 96
Change in Hemoglobin Levels
Tidsramme: At Week 0, 4, 12, 48 and 96

Change in hemoglobin levels to assess anaemia and nutritional status will be reported.
At Week 0, 4, 12, 48 and 96
Change in Platelets Levels
Tidsramme: At Week 0, 4, 12, 48 and 96

Change in platelets levels to assess anaemia and nutritional status will be reported.
At Week 0, 4, 12, 48 and 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment
Tidsramme: Baseline up to Week 96

Number of participants receiving concomitant medications for UC and CD will be reported.
Baseline up to Week 96
Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score
Tidsramme: Baseline (at Week 0), Weeks 12, 48 and 96

Health related quality of life changes as measured by SIBDQ will be reported. SIBDQ is a 10-item instrument developed to assess the participants perception of their health status specifically related to IBD over the past two weeks. The SIBDQ evaluates the following dimensions: psychological well-being (feelings of emotional health and stability), physical well-being (the impact of disease symptoms on physical health), social function (the influence of the disease on social activities and interactions) and digestive function (the effect of gastrointestinal symptoms on daily life). The total score ranges from 10 (worst health) to 70 (best health).
Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by Bowel Urgency
Tidsramme: Baseline (at Week 0), Weeks 12, 48 and 96

Health related quality of life changes as measured by bowel urgency will be reported. Change in bowel urgency for participants will be asked, that is, how severe were the bowel urgency.
Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by PRO-2 Components for Participants with CD
Tidsramme: Baseline (at Week 0), Weeks 12, 48 and 96

PRO-2 components that is change in SF and AP will be reported. Change in SF for participants will be asked, that is, how many bowel movements they had in last 24 hours, how many of those were very soft or liquid, or how many has occurred during the night. Change in AP for participants will be asked, that is, how severe was the abdominal pain in the last 24 hours.
Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by PRO-2 Components for Participants with UC
Tidsramme: Baseline (at Week 0), Weeks 12, 48 and 96

PRO-2 components that is change in SF and rectal bleeding will be reported. Change in SF for participants will be asked, that is, how many bowel movements they had in last 24 hours, how many of those were very soft or liquid, or how many has occurred during the night. Change in rectal bleeding for participants will be asked, that is, how severe were the rectal bleedings in the last 24 hours.
Baseline (at Week 0), Weeks 12, 48 and 96
HRQoL as Measured by IBD-Control Questionnaire (ICHOM)
Tidsramme: Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96

Health related quality of life changes as measured by ICHOM will be reported. ICHOM measures overall disease control from the participants perspective.
Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale
Tidsramme: Baseline (Week 0), 12, 48, and 96

FACIT-F scale is a 13-item instrument that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. It includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (for example, sleeping and social activities) over the last 7 days. The total FACIT-F score ranges from 0 to 52, with a higher score indicating less fatigue.
Baseline (Week 0), 12, 48, and 96
Number of Participants Achieving Endoscopic Response for Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)
Tidsramme: Baseline (at Week 0), Weeks 48 and 96

Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score <4.
Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Remission for Participants with CD as Measured by SES-CD
Tidsramme: Baseline (at Week 0), Weeks 48 and 96

Endoscopic remission is defined as SES-CD total score <4 with at least 2 points reduction from baseline and no sub-score >1 in any individual component.
Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Improvement for Participants with UC as Measured by Mayo Score
Tidsramme: Baseline (at Week 0), Weeks 48 and 96

Endoscopic Improvement is defined as a Mayo score <=1.
Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Normalization for Participants with UC as Measured by Mayo Score
Tidsramme: Baseline (at Week 0), Weeks 48 and 96

Endoscopic normalization is defined as a Mayo score =0.
Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Histologic Improvement
Tidsramme: At Weeks 0, 48 and 96

Histologic improvement is defined as neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=3.1.
At Weeks 0, 48 and 96
Number of Participants Achieving Histologic Remission
Tidsramme: At Weeks 0, 48 and 96

Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=2B.0.
At Weeks 0, 48 and 96
Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response
Tidsramme: Baseline (at Week 0), Weeks 24, 48, 72, and 96

IUS Response is defined as reduction of 25% in bowel wall thickness (BWT) or a reduction from baseline of BWT >2 millimeter (mm) or reduction from baseline BWT >1 mm plus a decrease from baseline in color doppler >1 point per baseline pathological segment.
Baseline (at Week 0), Weeks 24, 48, 72, and 96
Number of Participants with CD Achieving IUS Remission
Tidsramme: Baseline (at Week 0), Weeks 24, 48, 72, and 96

IUS Remission is defined as BWT <3 mm for ileum and colon plus Color Doppler signal (CDS) 0 in all segments.
Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM)
Tidsramme: Baseline (Week 0), Weeks 12, 48, and 96

TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction. It consists of 9 items distributed in the domains: side effects, effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100. with higher score indicating higher treatment satisfaction.
Baseline (Week 0), Weeks 12, 48, and 96
Change in Number of UC/CD Emergency Room Visits
Tidsramme: Baseline, Weeks 12, 48 and 96

Change in the number of emergency room visits for treatment of UC/CD will be reported.
Baseline, Weeks 12, 48 and 96
Change in Number of UC/CD-Hospitalizations
Tidsramme: Baseline, Weeks 12, 48 and 96

Change in the number of hospitalizations for treatment of UC/CD will be reported.
Baseline, Weeks 12, 48 and 96
Change in Number of UC/CD Surgeries
Tidsramme: Baseline, Weeks 12, 48 and 96

Change in the number of surgeries for treatment of UC/CD will be reported.
Baseline, Weeks 12, 48 and 96

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Janssen-Cilag Ltd.

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studieleder: Janssen-Cilag Limited Clinical Trial, Janssen-Cilag Limited

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)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
17. november 2025

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
5. marts 2029

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
17. marts 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
17. november 2025

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
17. november 2025

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
21. november 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
2. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • CNTO1959IBD4006
  • CNTO1959IBD4006 (Anden identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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