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Kopon, Zmudzinski I Wspolnicy Sp.j.","Torun","Kuyavian-Pomeranian Voivodeship","87-100",{"type":44,"coordinates":691},[692,693],18.59814,53.01375,{"lat":693,"lon":692},[696],{"name":697,"role":27,"phone":23,"phoneExt":23,"email":23},"Adam Kopon, MD",{"facility":699,"status":65,"city":700,"state":701,"zip":702,"country":662,"countryCode":663,"cosmosGeoPoint":703,"geoPoint":707,"contacts":708},"Melita Medical Sp Zoo","Wroclaw","Lower Silesian Voivodeship","53-611",{"type":44,"coordinates":704},[705,706],17.03006,51.10286,{"lat":706,"lon":705},[709],{"name":710,"role":27,"phone":23,"phoneExt":23,"email":23},"Jaroslaw Leszczyszyn, MD",{"facility":712,"status":65,"city":713,"state":714,"zip":715,"country":662,"countryCode":663,"cosmosGeoPoint":716,"geoPoint":720,"contacts":721},"Bodyclinic Sp.z.o.o. Sp.K","Warsaw","Masovia","03-712",{"type":44,"coordinates":717},[718,719],21.01178,52.22977,{"lat":719,"lon":718},[722],{"name":723,"role":27,"phone":23,"phoneExt":23,"email":23},"Piotr Gietka, MD",{"facility":725,"status":65,"city":713,"state":714,"zip":726,"country":662,"countryCode":663,"cosmosGeoPoint":727,"geoPoint":729,"contacts":730},"WIP Warsaw IBD Point Profesor Kierkus","04-501",{"type":44,"coordinates":728},[718,719],{"lat":719,"lon":718},[731],{"name":732,"role":27,"phone":23,"phoneExt":23,"email":23},"Jaroslaw Kierkus, MD",{"facility":734,"status":65,"city":735,"state":736,"zip":737,"country":662,"countryCode":663,"cosmosGeoPoint":738,"geoPoint":742,"contacts":743},"Centrum Medyczne Medyk","Rzeszów","Podkarpackie Voivodeship","35-326",{"type":44,"coordinates":739},[740,741],21.99901,50.04132,{"lat":741,"lon":740},[744],{"name":745,"role":27,"phone":23,"phoneExt":23,"email":23},"Rafal Filip, MD",{"facility":747,"status":65,"city":748,"state":749,"zip":750,"country":662,"countryCode":663,"cosmosGeoPoint":751,"geoPoint":755,"contacts":756},"Vita Longa Sp. z o.o.","Katowice","Silesian","40-748",{"type":44,"coordinates":752},[753,754],19.02173,50.2597,{"lat":754,"lon":753},[757],{"name":758,"role":27,"phone":23,"phoneExt":23,"email":23},"Przemyslaw Ramos, MD",{"facility":760,"status":65,"city":761,"state":762,"zip":763,"country":662,"countryCode":663,"cosmosGeoPoint":764,"geoPoint":768,"contacts":769},"Sonomed Sp. z o.o. - Centrum Medyczne","Szczecin","West Pomerianian","71-685",{"type":44,"coordinates":765},[766,767],14.55302,53.42894,{"lat":767,"lon":766},[770],{"name":771,"role":27,"phone":23,"phoneExt":23,"email":23},"Anna Wiechowska-Kozlowska, MD",{"facility":773,"status":37,"city":774,"state":23,"zip":23,"country":662,"countryCode":663,"cosmosGeoPoint":775,"geoPoint":779,"contacts":23},"Twoja Przychodnia-Centrum Medyczne Opole","Opole",{"type":44,"coordinates":776},[777,778],17.92604,50.67119,{"lat":778,"lon":777},{"facility":781,"status":65,"city":700,"state":23,"zip":782,"country":662,"countryCode":663,"cosmosGeoPoint":783,"geoPoint":785,"contacts":786},"EuroMediCare (EMC) Instytut Medyczny SA","54-144",{"type":44,"coordinates":784},[705,706],{"lat":706,"lon":705},[787],{"name":788,"role":27,"phone":23,"phoneExt":23,"email":23},"Patryk Smolinski, MD",{"facility":790,"status":51,"city":791,"state":23,"zip":23,"country":792,"countryCode":793,"cosmosGeoPoint":794,"geoPoint":798,"contacts":799},"LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria","Lisbon","Portugal","PT",{"type":44,"coordinates":795},[796,797],-9.1498,38.72509,{"lat":797,"lon":796},[800],{"name":801,"role":27,"phone":23,"phoneExt":23,"email":23},"Samuel Fernandes, MD",{"facility":803,"status":65,"city":804,"state":805,"zip":806,"country":807,"countryCode":808,"cosmosGeoPoint":809,"geoPoint":813,"contacts":814},"Nottingham University Hospitals NHS Trust - QMC","Nottingham","East Midlands","NG7 2UH","United Kingdom","UK",{"type":44,"coordinates":810},[811,812],-1.15047,52.9536,{"lat":812,"lon":811},[815],{"name":816,"role":27,"phone":23,"phoneExt":23,"email":23},"Sunil Samuel",{"facility":818,"status":37,"city":819,"state":820,"zip":821,"country":807,"countryCode":808,"cosmosGeoPoint":822,"geoPoint":826,"contacts":23},"London North West University Healthcare NHS Trust - Northwick Park Hospital","Harrow","Middlesex","HA1 3UJ",{"type":44,"coordinates":823},[824,825],-0.33208,51.57835,{"lat":825,"lon":824},{"facility":828,"status":51,"city":829,"state":23,"zip":830,"country":807,"countryCode":808,"cosmosGeoPoint":831,"geoPoint":835,"contacts":836},"Western General Hospital","Edinburgh","EH4 2XU",{"type":44,"coordinates":832},[833,834],-3.19648,55.95206,{"lat":834,"lon":833},[837,841],{"name":838,"role":31,"phone":839,"phoneExt":23,"email":840},"Debbie Alexander","+ 44 131 537 3858","debbie.alexander@ed.ac.uk",{"name":842,"role":27,"phone":23,"phoneExt":23,"email":23},"Nikolas Plevris, MD",{"facility":844,"status":65,"city":317,"state":23,"zip":845,"country":807,"countryCode":808,"cosmosGeoPoint":846,"geoPoint":850,"contacts":851},"Barts Health NHS Trust - The Royal London Hospital","E1 2AJ",{"type":44,"coordinates":847},[848,849],-0.12574,51.50853,{"lat":849,"lon":848},[852],{"name":853,"role":27,"phone":23,"phoneExt":23,"email":23},"Gareth Parkes, MD",{"facility":855,"status":65,"city":317,"state":23,"zip":856,"country":807,"countryCode":808,"cosmosGeoPoint":857,"geoPoint":859,"contacts":860},"University College London Hospitals NHS Foundation Trust","NW1 2BU",{"type":44,"coordinates":858},[848,849],{"lat":849,"lon":848},[861],{"name":862,"role":27,"phone":23,"phoneExt":23,"email":23},"Paul Harrow, MD",{"facility":864,"status":65,"city":317,"state":23,"zip":865,"country":807,"countryCode":808,"cosmosGeoPoint":866,"geoPoint":868,"contacts":869},"Kings College Hospital NHS Foundation Trust","SE5 9RS",{"type":44,"coordinates":867},[848,849],{"lat":849,"lon":848},[870],{"name":871,"role":27,"phone":23,"phoneExt":23,"email":23},"Polychronis Pavlidis",{"type":873,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[875],{"name":876,"class":877},"Takeda","INDUSTRY","100535890","phase-4-vectors---a-study-to-evaluate-transmural-healing-as-a-treatment-target-in-crohns-disease-100535890",false,"NCT06257706","VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease","An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease","VECTORS","Inclusion Criteria:\n\n1. Adults aged 18 to 80 years, inclusive, at the time of consent;\n2. Moderately to severely active CD at baseline defined by a CDAI score of 220 to 450 inclusive and SES-CD, excluding the presence of narrowing component, ≥6 (or ≥4 for participants with isolated ileal disease);\n3. BWT on IUS of \\>4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean of 2 longitudinal and 2 cross-sectional measurements of the same segment;\n4. Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD. Note: only approximately 15% to 30% of the enrolled population will have had prior exposure to an advanced therapeutic;\n5. Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;\n6. Persons of childbearing potential must have a negative serum pregnancy test prior to randomization and must use a highly effective method of contraception throughout the study. Females unable to bear children must have documentation of such in the source records;\n7. Able to participate fully in all aspects of this clinical trial;\n8. Written informed consent must be obtained and documented.\n\nExclusion Criteria:\n\n1. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;\n2. Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;\n3. Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \\>40 mg of prednisone or equivalent at randomization;\n4. Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;\n5. Have a CD complication, such as symptomatic strictures in the small bowel with \\>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;\n6. Previous extensive colonic resection or missing \\>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy;\n7. Ostomy or ileoanal pouch;\n8. Short bowel syndrome;\n9. Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;\n10. Abscess \\>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;\n11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety;\n12. Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);\n13. Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required;\n14. Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization;\n15. Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;\n16. Has active cerebral\u002Fmeningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;\n17. Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;\n18. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.\n19. Unwillingness to withhold protocol-prohibited medications during the trial;\n20. Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;\n21. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures;\n22. Prior enrolment in the current study and had received study treatment;\n23. Pregnant, lactating, or intending to become pregnant\u002Fimpregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;\n24. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;\n25. Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;\n26. The person is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).","ALL","18 Years","80 Years",{"count":890,"type":891},304,"ESTIMATED","INTERVENTIONAL",[894],"PHASE4","Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).\n\nQualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups.\n\nGroup 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.",[897,898,899],"Moderately to Severely Active Crohn's Disease","Crohn Disease","Disease Crohn","2026-01-14",{"date":902,"type":903},"2026-01-15","ACTUAL",{"date":905,"type":903},"2024-08-07",{"date":907,"type":891},"2029-02-06",{"name":5,"class":6},69]