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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004282-14 | EudraCT Number |
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This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etrolizumab + Placebo (IV) | Experimental | Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46. |
|
| Infliximab + Placebo (Injection) | Active Comparator | Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrolizumab | Drug | 105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS) | Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Week 10, Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission at Week 10, Defined as MCS ≤2 With Individual Subscores ≤1 | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. | Week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | 5020 | Austria | |||
| GZA Ziekenhuizen - Campus Sint-Vincentius |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34798038 | Derived | Danese S, Colombel JF, Lukas M, Gisbert JP, D'Haens G, Hayee B, Panaccione R, Kim HS, Reinisch W, Tyrrell H, Oh YS, Tole S, Chai A, Chamberlain-James K, Tang MT, Schreiber S; GARDENIA Study Group. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):118-127. doi: 10.1016/S2468-1253(21)00294-6. Epub 2021 Nov 17. | |
| 32445184 |
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Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Etrolizumab + Placebo (IV) | Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46. |
| FG001 | Infliximab + Placebo (Injection) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2018 | Jun 18, 2021 |
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| Infliximab | Drug | 5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46. |
|
| Placebo (IV) | Other | Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46. |
|
| Placebo (Injection) | Other | Administered by SC injection Q4W until Week 52 |
|
| Percentage of Participants Achieving Clinical Remission at Week 54, as Determined by the MCS |
Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. |
| Week 54 |
| Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Week 10 and Week 54 |
| Percentage of Participants Achieving Clinical Remission at Week 54 Among Those With a Clinical Response at Week 10, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. | Week 10 and Week 54 |
| Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1. | Baseline to Week 10 |
| Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1. | Baseline to Week 54 |
| Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Both Week 10 and Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1. | Baseline to Week 10, Week 54 |
| Percentage of Participants With Endoscopic Remission at Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Endoscopic Remission is Endoscopy subscore = 0. | Week 54 |
| Percentage of Participants Achieving Clinical Response at Week 10, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. | Week 10 |
| Percentage of Participants Achieving Clinical Response at Both Weeks 10 and 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. | Week 10, Week 54 |
| Percentage of Participants That Achieve Clinical Remission Corticosteroid-Free at Week 54 (Off Corticosteroid for at Least 24 Weeks Prior to Week 54) Among Those Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Week 54 |
| Number of Participants With Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Baseline until the end of study (up to 66 weeks) |
| Number of Participants With Adverse Events Leading to Study Drug Discontinuation | Baseline until the end of study (up to 66 weeks) |
| Number of Participants With Infection-Related Adverse Events, Severity Determined According to the NCI CTCAE v4.0 | All AEs were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Baseline until the end of study (up to 66 weeks) |
| Number of Participants With Serious Infection-Related Adverse Events | Baseline until the end of study (up to 66 weeks) |
| Number of Participants With Malignancies | Baseline until the end of study (up to 66 weeks) |
| Number of Participants With Injection-Site Reactions, Severity Determined According to the NCI CTCAE v4.0 | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Baseline until the end of study (up to 66 weeks) |
| Number of Participants With Hypersensitivity Reaction Events, Severity Determined According to the NCI CTCAE v4.0 | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Baseline until the end of study (up to 66 weeks) |
| Pharmacokinetics: Etrolizumab Serum Concentration | Weeks 2, 10, 12, 30, and 54 |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Overall Score at Weeks 10, 30, and 54 | The IBDQ is used to assess participant's health-related quality of life (QOL). The 32-item questionnaire contains four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale with a higher score indicating better health-related QOL. IBDQ score is a total score summed up from across all 32 questions on the questionnaire. The score can range from 32-224 and the higher score indicates a better quality of life. | Weeks 10, 30, and 54 |
| Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab | Weeks 0, 4, 10, 12, 30, and 54 |
| Antwerp |
| 2018 |
| Belgium |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| CHU St Pierre (St Pierre) | Brussels | 1000 | Belgium |
| Universitair Ziekenhuis Brussel; Neurology | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc; Pharmacy | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Sint Elisabeth Herentals | Herentals | 2200 | Belgium |
| University of Calgary; Heritage Medical Research Clinic | Calgary | Alberta | T2N 4Z6 | Canada |
| Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology | Edmonton | Alberta | T6G 2X8 | Canada |
| Guelph GI & Surgery Clinic | Guelph | Ontario | N1H 3R3 | Canada |
| Centre de santé et de services sociaux Champlain-Charles-Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hôpital Maisonneuve - Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Vojenska nemocnice Brno | Brno | 636 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum | Kladno | 272 59 | Czechia |
| Mestska Nemocnice Ostrava | Ostrava | 728 80 | Czechia |
| Pardubicka krajska nemocnice, a.s. | Pardubice | 532 03 | Czechia |
| ISCARE a.s. | Prague | 170 04 | Czechia |
| Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni | Ústí nad Labem | 401 13 | Czechia |
| Krajska nemocnice T. Bati, a.s. | Zlín | 76001 | Czechia |
| CHU de Caen - Hopital Cote de Nacre | Caen | 14033 | France |
| CHU Tours - Hôpital Trousseau | Chambray-lès-Tours | 37170 | France |
| CHU Clermont Ferrand - Hôtel Dieu | Clermont-Ferrand | 63000 | France |
| Hôpital Beaujon | Clichy | 92110 | France |
| CHU Hopital Saint Eloi | Montpellier | 34295 | France |
| CHU Nice - Hopital de l'Archet 2 | Nice | 06202 | France |
| Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie | Pierre-Bénite | 69495 | France |
| Hôpital de Brabois Adultes | Vandœuvre-lès-Nancy | 54511 | France |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12200 | Germany |
| DRK Kliniken Berlin Westend | Berlin | 14050 | Germany |
| Krankenhaus Waldfriede e. V. | Berlin | 14163 | Germany |
| Universitätsklinikum Koeln | Cologne | 50937 | Germany |
| Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation | Freiburg im Breisgau | 79106 | Germany |
| Gastroenterologie Eppendorfer Baum | Hamburg | 20249 | Germany |
| Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24116 | Germany |
| Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza | Békéscsaba | 5600 | Hungary |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo | Budapest | 1125 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely | Budapest | H-1077 | Hungary |
| Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft | Debrecen | 4025 | Hungary |
| Markhot Ferenc Oktato Korhaz es Rendelointezet | Eger | 3300 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat | Miskolc | 3526 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | 6720 | Hungary |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | 8000 | Hungary |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit | Tel Litwinsky | 52621 | Israel |
| Azienda Ospedaliero Universitaria di Parma | Parma | Emilia-Romagna | 43100 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | Lazio | 00133 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 00152 | Italy |
| Asst Fatebenefratelli Sacco (Fatebenefratelli) | Milan | Lombardy | 20121 | Italy |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) | Milan | Lombardy | 20162 | Italy |
| Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) | Milan | Lombardy | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | 20089 | Italy |
| I.R.C.C.S Policlinico San Donato | San Donato Milanese (MI) | Lombardy | 20097 | Italy |
| IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest | San Giovanni Rotondo | Lombardy | 71013 | Italy |
| Ospedale Mauriziano Umberto I | Turin | Piedmont | 10128 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | 50141 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| Azienda Ospedaliera Di Padova | Padova | Veneto | 35128 | Italy |
| Amsterdam UMC Location VUMC | Amsterdam | 1081 HV | Netherlands |
| Amsterdam UMC Location AMC | Amsterdam | 1105 AZ | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Radboudumc | NL -nijmegen | 6525 GA | Netherlands |
| Akershus universitetssykehus HF | Lørenskog | 1478 | Norway |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Hospital da Senhora da Oliveira Guimarães | Guimarães | 4835-044 | Portugal |
| S.C MedLife S.A | Bucharest | 010719 | Romania |
| Institutul Clinic Fundeni Bucuresti | Bucharest | 022328 | Romania |
| Centrul Medical Unirea SRL | Bucharest | 040055 | Romania |
| Spitalul Clinic Colentina | Bucharest | 772202 | Romania |
| Spitalul Clinic Judetean Mures | Târgu Mureş | 540103 | Romania |
| Centrul de Gastroenterologie Dr. Goldis | Timișoara | 300002 | Romania |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Netcare Universitas Private Hospital | Bloemfontein | 9301 | South Africa |
| Dr MJ Prins Practice | Cape Town | 7500 | South Africa |
| Dr Corne Kruger Inc. | Cape Town | 7550 | South Africa |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Yeungnam Univ. Hospital | Daegu | 705-717 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | South Korea |
| CHA Bundang Medical Centre; CHA university | Seongnam | 13520 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital, Yonsei University | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea St. Vincent's Hospital | Suwon | 442-723 | South Korea |
| Ajou University Hospital | Suwon | 443-721 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 220-701 | South Korea |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Complejo Hospitalario Universitario de Ferrol | Ferrol | LA Coruña | 15405 | Spain |
| Fundacion Hospital de Alcorcon; Servicio de Digestivo | Alcorcón | Madrid | 28922 | Spain |
| Centro Médico Teknon | Barcelona | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario La Paz | Madrid | 280146 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Danderyds Sjukhus AB | Stockholm | 18288 | Sweden |
| Inselspital-Universitaetsspital Bern | Bern | 3010 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| The Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | EX2 5DW | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| The Royal London Hospital | London | E1 1FR | United Kingdom |
| St Thomas Hospital | London | SE1 7EH | United Kingdom |
| King's College London | London | SE5 9NU | United Kingdom |
| Fairfield General Hospital | Manchester | M8 5RB | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22. |
Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etrolizumab + Placebo (IV) | Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46. |
| BG001 | Infliximab + Placebo (Injection) | Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Mayo Clinic Score (MCS) ≤9 or ≥10 at Baseline | Measure Description: Participants were stratified by concomitant treatment with corticosteroids (yes/no) at randomization, concomitant treatment with immunosuppressants (yes/no) at randomization, and disease activity measured during screening (MCS ≤9/MCS ≥10). The MCS ranges from 0 to 12 and is a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease. | For the Infliximab arm, only 197 subjects had MCS categorical scores available for baseline. | Count of Participants | Participants |
| ||||||||||||||
| Baseline Treatment: None, Corticosteroids (CS) or Immunosuppressants (IS) Alone, or Both CS and IS | Participants were stratified by concomitant treatment with corticosteroids (yes/no) at randomization, concomitant treatment with immunosuppressants (yes/no) at randomization, and disease activity measured during screening (MCS ≤9/MCS ≥10). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS) | Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Posted | Number | percentage of participants | Week 10, Week 54 |
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| Secondary | Percentage of Participants Achieving Clinical Remission at Week 10, Defined as MCS ≤2 With Individual Subscores ≤1 | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. | Posted | Number | percentage of participants | Week 10 |
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| Secondary | Percentage of Participants Achieving Clinical Remission at Week 54, as Determined by the MCS | Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Posted | Number | percentage of participants | Week 54 |
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| Secondary | Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Posted | Number | percentage of participants | Week 10 and Week 54 |
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| Secondary | Percentage of Participants Achieving Clinical Remission at Week 54 Among Those With a Clinical Response at Week 10, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. | Participants that achieved a Clinical Response at Week 10 | Posted | Number | percentage of participants | Week 10 and Week 54 |
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| Secondary | Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1. | Posted | Number | percentage of participants | Baseline to Week 10 |
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| Secondary | Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1. | Posted | Number | percentage of participants | Baseline to Week 54 |
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| Secondary | Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Both Week 10 and Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1. | Posted | Number | percentage of participants | Baseline to Week 10, Week 54 |
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| Secondary | Percentage of Participants With Endoscopic Remission at Week 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Endoscopic Remission is Endoscopy subscore = 0. | Posted | Number | percentage of participants | Week 54 |
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| Secondary | Percentage of Participants Achieving Clinical Response at Week 10, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. | Posted | Number | percentage of participants | Week 10 |
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| Secondary | Percentage of Participants Achieving Clinical Response at Both Weeks 10 and 54, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. | Posted | Number | percentage of participants | Week 10, Week 54 |
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| Secondary | Percentage of Participants That Achieve Clinical Remission Corticosteroid-Free at Week 54 (Off Corticosteroid for at Least 24 Weeks Prior to Week 54) Among Those Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Participants that were receiving corticosteroids at baseline | Posted | Number | percentage of participants | Week 54 |
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| Secondary | Number of Participants With Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Posted | Number | participants | Baseline until the end of study (up to 66 weeks) |
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| Secondary | Number of Participants With Adverse Events Leading to Study Drug Discontinuation | Posted | Number | participants | Baseline until the end of study (up to 66 weeks) |
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| Secondary | Number of Participants With Infection-Related Adverse Events, Severity Determined According to the NCI CTCAE v4.0 | All AEs were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Posted | Number | participants | Baseline until the end of study (up to 66 weeks) |
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| Secondary | Number of Participants With Serious Infection-Related Adverse Events | Posted | Number | participants | Baseline until the end of study (up to 66 weeks) |
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| Secondary | Number of Participants With Malignancies | Posted | Number | participants | Baseline until the end of study (up to 66 weeks) |
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| Secondary | Number of Participants With Injection-Site Reactions, Severity Determined According to the NCI CTCAE v4.0 | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Posted | Number | participants | Baseline until the end of study (up to 66 weeks) |
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| Secondary | Number of Participants With Hypersensitivity Reaction Events, Severity Determined According to the NCI CTCAE v4.0 | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Posted | Number | participants | Baseline until the end of study (up to 66 weeks) |
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| Secondary | Pharmacokinetics: Etrolizumab Serum Concentration | A subset of etrolizumab-treated participants who received at least one dose of study drug and had at least one quantifiable concentration measured post baseline. | Posted | Mean | Standard Deviation | microgram/milliliter | Weeks 2, 10, 12, 30, and 54 |
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| Secondary | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Overall Score at Weeks 10, 30, and 54 | The IBDQ is used to assess participant's health-related quality of life (QOL). The 32-item questionnaire contains four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale with a higher score indicating better health-related QOL. IBDQ score is a total score summed up from across all 32 questions on the questionnaire. The score can range from 32-224 and the higher score indicates a better quality of life. | Participants that completed the IBDQ Questionnaire at baseline and at the respective Time Points | Posted | Mean | Standard Deviation | scores on a scale | Weeks 10, 30, and 54 |
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| Secondary | Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab | A subset of etrolizumab-treated participants with at least one baseline or post-baseline ATA result from at least one sample. | Posted | Number | participants | Weeks 0, 4, 10, 12, 30, and 54 |
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|
Baseline until the end of study (up to 66 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etrolizumab + Placebo (IV) | Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46. | 0 | 199 | 32 | 199 | 94 | 199 |
| EG001 | Infliximab + Placebo (Injection) | Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52. | 1 | 198 | 20 | 198 | 80 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Cytomegalovirus colitis | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Meningitis listeria | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Stitch abscess | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA version 23.0 | Non-systematic Assessment |
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| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA version 23.0 | Non-systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 23.0 | Non-systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 23.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA version 23.0 | Non-systematic Assessment |
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| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | Non-systematic Assessment |
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| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | Non-systematic Assessment |
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| Central nervous system vasculitis | Nervous system disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2020 | Jun 18, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C559198 | etrolizumab |
| D000069285 | Infliximab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
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| Black or African American |
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| White |
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| Other |
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| MCS ≥10 |
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| Immunosuppressants (IS) Alone |
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| Both CS and IS |
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| None |
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| Participants |
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| Title | Denominators | Categories | ||||
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| Week 2 |
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| Week 10 |
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| Week 12 |
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| Week 32 |
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| Week 54 |
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