[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658464":3},{"organization":4,"outcomesModule":7,"designInfo":152,"detailedDescription":151,"studyPopulation":155,"armGroups":156,"interventions":151,"overallOfficials":160,"centralContacts":165,"locations":151,"responsibleParty":171,"collaborators":151,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":175,"sex":181,"minAge":182,"maxAge":151,"enrollmentInfo":183,"targetDuration":151,"studyType":186,"phases":151,"briefSummary":187,"conditions":188,"keywords":151,"overallStatus":192,"whyStopped":151,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":151},{"fullName":5,"class":6},"Janssen-Cilag Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":151},[9],{"measure":10,"description":11,"timeFrame":12},"Persistence of Treatment with Guselkumab","Persistence of treatment with guselkumab will be defined as the time elapsed from the date of the first administration of guselkumab to its discontinuation date. The discontinuation date will be defined as the date that the next administration of guselkumab should have taken place for a paticipant after the last dose of treatment was administered.","Up to Week 96",[14,18,21,24,27,30,33,36,40,43,46,49,52,55,58,61,64,67,70,73,76,79,82,86,89,92,95,98,101,104,107,110,113,116,119,122,125,128,131,135,138,141,144,147],{"measure":15,"description":16,"timeFrame":17},"Percentage of Participants with Early Responses to Guselkumab Measured Using Patient Reported Outcome (PRO-2) for Crohn's Disease (CD)","Percentage of participants with early responses to guselkumab will be assessed using PRO-2, including stool frequency and abdominal pain in CD participants through the patient's electronic (e)-diary.","Up to Week 12",{"measure":19,"description":20,"timeFrame":17},"Percentage of Participants with Early Responses to Guselkumab Measured Using PRO-2 for Ulcerative Colitis (UC)","Percentage of participants with early responses to guselkumab will be assessed using PRO-2, including stool frequency and rectal bleeding in UC participants through the patient's e-diary.",{"measure":22,"description":23,"timeFrame":17},"Percentage of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency (BU)","Percentage of participants with early responses to guselkumab using bowel urgency will be assessed and reported via patient e-diary. BU is defined as the sudden or immediate need to have a bowel movement, will be assessed using both a qualitative and a quantitative approach. For the qualitative assessment the presence as a binary yes\u002Fno outcome of the symptoms will be collected; for the quantitative assessment the severity of BU will be evaluated using the urgency numerical rating scale (UNRS) ranging from 0 to 10, where 0 = no urgency and 10 = worst possible urgency.",{"measure":25,"description":26,"timeFrame":12},"Percentage of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI)","Percentage of participants reporting effectiveness with treatment guselkumab will be measured through the HBI for CD. The HBI consists of a 5-part questionnaire, assessing general wellbeing, AP, 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 (\\\u003C=) 4 or a decrease in HBI by greater than or equal to (\\>=) 3 from baseline.",{"measure":28,"description":29,"timeFrame":12},"Percentage of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS)","Percentage of participants reporting effectiveness with treatment guselkumab will be measured through the PMS for UC. The PMS comprises 3 categories: rectal bleeding, stool frequency, and physician assessment. Clinical response for UC is defined as the PMS score less than (\\\u003C) 4 or \\>= 30 percent (%) reduction from baseline.",{"measure":31,"description":32,"timeFrame":12},"Percentage of Participants Achieving Corticosteroid-free Clinical Remission and PRO-2 for UC","Corticosteroid-free clinical remission for UC is defined as no use of steroids for at least 30 days and PMS less than (\\\u003C) 2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.",{"measure":34,"description":35,"timeFrame":12},"Percentage of Participants Achieving Corticosteroid-free Clinical Remission and PRO-2 for CD","Corticosteroid-free clinical remission for CD is defined as no use of steroids for at least 30 days and HBI score less than or equal to (\\\u003C=)4. HBI score is used to assess disease severity and treatment effectiveness.",{"measure":37,"description":38,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Age","Age of participants receiving guselkumab treatment will be reported.","At Week 0",{"measure":41,"description":42,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Sex","Sex of participants receiving guselkumab treatment will be reported.",{"measure":44,"description":45,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Weight","Weight of participants receiving guselkumab treatment will be reported.",{"measure":47,"description":48,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Body Mass Index (BMI)","BMI of participants receiving guselkumab treatment will be reported.",{"measure":50,"description":51,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Vital Signs [Systolic Blood Pressure {SBP} and Diastolic Blood Pressure {DBP}]","Vital signs (SBP and DBP) of participants will be reported.",{"measure":53,"description":54,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Comorbidities","Number of participants with comorbidities will be reported.",{"measure":56,"description":57,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History","Number of participants with smoking status and history will be reported.",{"measure":59,"description":60,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Inflammatory Bowel Disease (IBD) Related Data","Participants IBD related data at diagnosis will be reported.",{"measure":62,"description":63,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis of UC\u002FCD","Participants age at diagnosis will be reported.",{"measure":65,"description":66,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Previous Diagnosis of Plaque Psoriasis, Arthritic Psoriasis, Previous Use of IBD Treatment","Participants with a previous diagnosis of plaque psoriasis, arthritic psoriasis and previous use of IBD treatment will be reported.",{"measure":68,"description":69,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity","Participants reporting the disease severity will be assessed.",{"measure":71,"description":72,"timeFrame":39},"Characteristics of Participants with CD Receiving Guselkumab Treatment: Disease Location","Participants disease location will be assessed.",{"measure":74,"description":75,"timeFrame":39},"Characteristics of Participants with UC Receiving Guselkumab Treatment: Disease Extent","Participants disease extent will be assessed.",{"measure":77,"description":78,"timeFrame":39},"Characteristics of Participants Receiving Guselkumab Treatment: Presence of Extraintestinal Manifestations","Participants with presence of extraintestinal manifestations will be assessed.",{"measure":80,"description":81,"timeFrame":12},"Percentage of Participants with Adverse Events (AEs) During Treatment with Guselkumab","An adverse event is any untoward medical occurrence in a participant 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.",{"measure":83,"description":84,"timeFrame":85},"Change in C-reactive protein (CRP) Levels","Change in CRP levels since guselkumab initiation will be reported. CRP is a marker of inflammation that will be measured by physicians following routine clinical practice.","Baseline (Week 0) up to Week 96",{"measure":87,"description":88,"timeFrame":85},"Change in Faecal Calprotectin (Fcal) Levels","Change in Fcal levels since guselkumab initiation will be reported. The Fcal is a marker of inflammation that will be measured by physicians following routine clinical practice.",{"measure":90,"description":91,"timeFrame":12},"Percentage of Participants Receiving Concomitant IBD Medications","Percentage of participants receiving concomitant IBD medications for UC and CD will be reported.",{"measure":93,"description":94,"timeFrame":85},"Change in Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scale Score","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).",{"measure":96,"description":97,"timeFrame":85},"Change in Fatigue Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale Score","FACIT-F scale is a 13-item instrument that evaluates fatigue\u002Ftiredness 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.",{"measure":99,"description":100,"timeFrame":12},"Percentage of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)","Endoscopic response in participants with CD is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score \\\u003C4.",{"measure":102,"description":103,"timeFrame":12},"Percentage of Participants Achieving Endoscopic Remission in Participants with CD as Measured by SES-CD","Endoscopic remission in participants with CD is defined as SES-CD total score \\\u003C=4 with at least 2 points reduction from baseline (Week 0) and no sub-score \\>1 in any individual component total score (terminal ileum, right colon, transverse colon, left colon, rectum).",{"measure":105,"description":106,"timeFrame":12},"Percentage of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score","Endoscopic improvement in participants with UC is defined as a Mayo endoscopic score (MES) \\\u003C=1.",{"measure":108,"description":109,"timeFrame":12},"Percentage of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score","Endoscopic normalization in participants with UC is defined as a Mayo score =0.",{"measure":111,"description":112,"timeFrame":12},"Percentage of Participants Achieving Histologic Improvement","Histologic improvement is defined as neutrophil infiltration in \\\u003C5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score \\\u003C=3.1.",{"measure":114,"description":115,"timeFrame":12},"Percentage of Participants Achieving Histologic Remission","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 \\\u003C=2B.0.",{"measure":117,"description":118,"timeFrame":12},"Percentage of Participants with CD Achieving Intestinal Ultrasound (IUS) Response","IUS (transmural) response in CD participants is defined as reduction of bowel wall thickness (BWT) of \\>=25% or normalization \\[\\\u003C=3 millimeter {mm}\\] of the most affected segment.",{"measure":120,"description":121,"timeFrame":12},"Percentage of Participants with CD Achieving IUS Remission","IUS (transmural) remission in CD participants is defined as normalization of BWT (\\\u003C=3 mm) and vascularity (no signal or short signal in color doppler of the most affected segment), in participants with increased BWT (\\>3 mm) or alternatively a Bowel Ultrasound Score (BUSS) \\\u003C=3.52.",{"measure":123,"description":124,"timeFrame":12},"Percentage of Participants with UC Achieving IUS Response","IUS response is defined as a decrease in Milan Ultrasound Criteria (MUC) \\>=2 points. The MUC is a validated ultrasound-based scoring system used to assess disease activity in UC. It combines BWT and vascularization (using Doppler imaging) to predict disease course.",{"measure":126,"description":127,"timeFrame":12},"Percentage of Participants with UC Achieving IUS Remission","IUS Remission is defined as normalization of BWT and of all other IUS parameters or as a MUC \\\u003C 4.3. The MUC is a validated ultrasound-based scoring system used to assess disease activity in UC. It combines BWT and vascularization (using Doppler imaging) to predict disease course. MUC score \\\u003C 4.3 is considered a significant indicator of endoscopic remission MES= 0.",{"measure":129,"description":130,"timeFrame":85},"Change from Baseline in Satisfaction with Guselkumab Treatment Using Treatment Satisfaction Questionnaire for Medication (TSQM)","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.",{"measure":132,"description":133,"timeFrame":134},"Percentage of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries","Percentage of participants receiving previous IBD-related surgeries will be reported.","Up to 12 months",{"measure":136,"description":137,"timeFrame":12},"Change in Number of UC\u002FCD Emergency Room Visits","Change in the number of emergency room visits for treatment of UC\u002FCD will be reported.",{"measure":139,"description":140,"timeFrame":12},"Change in Number of UC\u002FCD-Hospitalizations","Change in the number of hospitalizations for treatment of UC\u002FCD will be reported.",{"measure":142,"description":143,"timeFrame":12},"Change in Number of UC\u002FCD Surgeries","Change in the number of surgeries for treatment of UC\u002FCD will be reported.",{"measure":145,"description":146,"timeFrame":85},"Change from Baseline in Disability Assessed Through the Modified (m)IBD-Disk Score","mIBD-disk includes 10+1 items assessing abdominal pain, defecation, social life, professional life, sleep, energy, anxiety, self-image, sexual functions, joint pain and dietary habits. Participants rate each item on an 11-point visual analogue scale, ranging from 0 (\"absolutely disagree\") to 10 (\"absolutely agree\"). An average total IBD-Disk score of 40 (44 for the mIBD version) or higher is generally associated with a moderate-to-severe level of disability in individuals with IBD.",{"measure":148,"description":149,"timeFrame":150},"Change from Baseline in Presence and Evolution of Extra-Intestinal Manifestations (EIMs)","The assessment of the evolution of EIMs during guselkumab treatment will be performed by the physician on a 4-point Likert scale (1 = Recovered: the EIM has resolved completely; 2 = Improved: the EIM has shown clinical improvement but is not fully resolved. 3 = Unchanged: no change in the severity or status of the EIM; 4 = Worsened: the EIM has deteriorated or increased in severity from previous visit).","Baseline up to Week 96",null,{"allocation":151,"interventionModel":151,"interventionModelDescription":151,"primaryPurpose":151,"observationalModel":153,"timePerspective":154,"maskingInfo":151},"COHORT","PROSPECTIVE","The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.",[157],{"label":158,"type":151,"description":159,"interventionNames":151},"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, according to the summary of product characteristics (SmPC) and local guidelines will be enrolled. Only data available from clinical routine will be collected in this study.",[161],{"name":162,"affiliation":163,"role":164},"Janssen Cilag SpA Clinical Trial","Janssen Cilag SpA","STUDY_DIRECTOR",[166],{"name":167,"role":168,"phone":169,"phoneExt":151,"email":170},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",{"type":172,"investigatorFullName":151,"investigatorTitle":151,"investigatorAffiliation":151,"oldNameTitle":151,"oldOrganization":151},"SPONSOR","100658464","a-study-to-assess-guselkumab-in-participants-with-moderate-to-severe-inflammatory-bowel-disease-in-real-life-italian-setting-100658464",false,"NCT07851207","A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting","Guselkumab Assessment in Moderate-to-Severe Inflammatory Bowel Disease (IBD) Observational Study in a Real Life Italian Setting","GLAMOUR","Inclusion criteria:\n\n* The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in the medical records\n* The participant must be eligible for biologic treatment and scheduled to initiate treatment with guselkumab for CD or UC management as per physician decision under routine clinical practice conditions, and according to the summary of product characteristics (SmPC) of the drug\n* The participant has provided signed informed consent\n\nExclusion criteria:\n\n* The participant is currently enrolled in an interventional clinical study\n* The participant has been previously exposed to interleukin (IL)-23 inhibitors, including guselkumab (Tremfya), risankizumab (Skyrizi) or mirikizumab (Omvoh). As an exception, participants who had previously received ustekinumab may be included\n* The participant has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy, including biologics and\u002For small molecules\n* The participant is unable to provide the informed consent form (ICF) and\u002For unable to complete the questionnaires\u002Fscales and patient's diary to address the study objectives","ALL","18 Years",{"count":184,"type":185},200,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).",[189,190,191],"Colitis, Ulcerative","Crohn Disease","Inflammatory Bowel Diseases","NOT_YET_RECRUITING","2026-09-25",{"date":195,"type":196},"2026-10-01","ACTUAL",{"date":198,"type":185},"2026-10-05",{"date":200,"type":185},"2029-07-31",{"name":5,"class":6}]