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A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors (GARDENIA)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etrolizumab
Infliximab
Placebo (IV)
Placebo (Injection)
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
  • Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars)
  • An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
  • Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
  • Use of highly effective contraception during and at least 24 weeks after the last dose of study drug

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
  • Prior or planned surgery for UC
  • Past or present ileostomy or colostomy
  • Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, efalizumab, and tofactinib)
  • History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients
  • Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)

Sites / Locations

  • LKH - Universitätsklinikum der PMU Salzburg
  • GZA Ziekenhuizen - Campus Sint-Vincentius
  • Imeldaziekenhuis
  • CHU St Pierre (St Pierre)
  • Universitair Ziekenhuis Brussel; Neurology
  • Cliniques Universitaires Saint-Luc; Pharmacy
  • UZ Gent
  • AZ Sint Elisabeth Herentals
  • University of Calgary; Heritage Medical Research Clinic
  • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
  • Guelph GI & Surgery Clinic
  • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
  • Hôpital Maisonneuve - Rosemont
  • Royal University Hospital
  • Vojenska nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
  • Mestska Nemocnice Ostrava
  • Pardubicka krajska nemocnice, a.s.
  • ISCARE a.s.
  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
  • Krajska nemocnice T. Bati, a.s.
  • CHU de Caen - Hopital Cote de Nacre
  • CHU Tours - Hôpital Trousseau
  • CHU Clermont Ferrand - Hôtel Dieu
  • Hôpital Beaujon
  • CHU Hopital Saint Eloi
  • CHU Nice - Hopital de l'Archet 2
  • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
  • Hôpital de Brabois Adultes
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • DRK Kliniken Berlin Westend
  • Krankenhaus Waldfriede e. V.
  • Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
  • Gastroenterologie Eppendorfer Baum
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Universitätsklinikum Koeln
  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  • Semmelweis Egyetem
  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
  • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
  • Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft
  • Markhot Ferenc Oktato Korhaz es Rendelointezet
  • Petz Aladar Megyei Oktato Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Rabin Medical Center-Beilinson Campus
  • Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
  • Azienda Ospedaliero Universitaria di Parma
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Azienda Ospedaliera San Camillo Forlanini
  • Asst Fatebenefratelli Sacco (Fatebenefratelli)
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Istituto Clinico Humanitas
  • I.R.C.C.S Policlinico San Donato
  • IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
  • Ospedale Mauriziano Umberto I
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera Di Padova
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Kyungpook National University Chilgok Hospital
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Yeungnam Univ. Hospital
  • Korea University Ansan Hospital
  • Seoul National University Bundang Hospital
  • CHA Bundang Medical Centre; CHA university
  • Kyung Hee University Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University
  • Asan Medical Center
  • Samsung Medical Center
  • Ajou University Hospital
  • The Catholic University of Korea St. Vincent's Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Amsterdam UMC Location VUMC
  • Amsterdam UMC Location AMC
  • Maastricht University Medical Center
  • Radboudumc
  • Akershus universitetssykehus HF
  • Hospital de Braga
  • Hospital da Senhora da Oliveira Guimarães
  • Institutul Clinic Fundeni Bucuresti
  • Spitalul Clinic Colentina
  • S.C MedLife S.A
  • Centrul Medical Unirea SRL
  • Spitalul Clinic Judetean Mures
  • Centrul de Gastroenterologie Dr. Goldis
  • Singapore General Hospital
  • Netcare Universitas Private Hospital
  • Dr MJ Prins Practice
  • Dr Corne Kruger Inc.
  • Corporacio Sanitaria Parc Tauli
  • Complejo Hospitalario Universitario de Ferrol
  • Fundacion Hospital de Alcorcon; Servicio de Digestivo
  • Centro Médico Teknon
  • Hospital Universitario de la Princesa
  • Hospital Universitario La Paz
  • Hospital Universitari i Politecnic La Fe
  • Danderyds Sjukhus AB
  • Inselspital-Universitaetsspital Bern
  • Universitätsspital Zürich
  • The Royal Bournemouth Hospital
  • Addenbrooke's Hospital
  • University Hospital Coventry
  • Royal Devon and Exeter Hospital (Wonford)
  • St James University Hospital
  • The Royal London Hospital
  • St Thomas Hospital
  • King's College London
  • Fairfield General Hospital
  • Royal Victoria Infirmary
  • Nottingham University Hospitals NHS Trust
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Etrolizumab + Placebo (IV)

Infliximab + Placebo (Injection)

Arm Description

Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
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.
Number of Participants With Serious Infection-Related Adverse Events
Number of Participants With Malignancies
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.
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.
Pharmacokinetics: Etrolizumab Serum Concentration
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.
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab

Full Information

First Posted
April 15, 2014
Last Updated
December 1, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02136069
Brief Title
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
Acronym
GARDENIA
Official Title
Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 24, 2014 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
June 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etrolizumab + Placebo (IV)
Arm Type
Experimental
Arm Description
Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.
Arm Title
Infliximab + Placebo (Injection)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etrolizumab
Other Intervention Name(s)
PRO145223, RO5490261, RG7413
Intervention Description
105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo (IV)
Intervention Description
Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
Intervention Type
Other
Intervention Name(s)
Placebo (Injection)
Intervention Description
Administered by SC injection Q4W until Week 52
Primary Outcome Measure Information:
Title
Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS)
Description
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.
Time Frame
Week 10, Week 54
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission at Week 10, Defined as MCS ≤2 With Individual Subscores ≤1
Description
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.
Time Frame
Week 10
Title
Percentage of Participants Achieving Clinical Remission at Week 54, as Determined by the MCS
Description
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.
Time Frame
Week 54
Title
Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54, as Determined by the MCS
Description
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.
Time Frame
Week 10 and Week 54
Title
Percentage of Participants Achieving Clinical Remission at Week 54 Among Those With a Clinical Response at Week 10, as Determined by the MCS
Description
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.
Time Frame
Week 10 and Week 54
Title
Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, Determined by the MCS
Description
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.
Time Frame
Baseline to Week 10
Title
Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 54, as Determined by the MCS
Description
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.
Time Frame
Baseline to Week 54
Title
Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Both Week 10 and Week 54, as Determined by the MCS
Description
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.
Time Frame
Baseline to Week 10, Week 54
Title
Percentage of Participants With Endoscopic Remission at Week 54, as Determined by the MCS
Description
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.
Time Frame
Week 54
Title
Percentage of Participants Achieving Clinical Response at Week 10, as Determined by the MCS
Description
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.
Time Frame
Week 10
Title
Percentage of Participants Achieving Clinical Response at Both Weeks 10 and 54, as Determined by the MCS
Description
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.
Time Frame
Week 10, Week 54
Title
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
Description
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.
Time Frame
Week 54
Title
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)
Description
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.
Time Frame
Baseline until the end of study (up to 66 weeks)
Title
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Time Frame
Baseline until the end of study (up to 66 weeks)
Title
Number of Participants With Infection-Related Adverse Events, Severity Determined According to the NCI CTCAE v4.0
Description
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.
Time Frame
Baseline until the end of study (up to 66 weeks)
Title
Number of Participants With Serious Infection-Related Adverse Events
Time Frame
Baseline until the end of study (up to 66 weeks)
Title
Number of Participants With Malignancies
Time Frame
Baseline until the end of study (up to 66 weeks)
Title
Number of Participants With Injection-Site Reactions, Severity Determined According to the NCI CTCAE v4.0
Description
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.
Time Frame
Baseline until the end of study (up to 66 weeks)
Title
Number of Participants With Hypersensitivity Reaction Events, Severity Determined According to the NCI CTCAE v4.0
Description
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.
Time Frame
Baseline until the end of study (up to 66 weeks)
Title
Pharmacokinetics: Etrolizumab Serum Concentration
Time Frame
Weeks 2, 10, 12, 30, and 54
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Overall Score at Weeks 10, 30, and 54
Description
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.
Time Frame
Weeks 10, 30, and 54
Title
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Time Frame
Weeks 0, 4, 10, 12, 30, and 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS) Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars) An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period Use of highly effective contraception during and at least 24 weeks after the last dose of study drug Exclusion Criteria: A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps Prior or planned surgery for UC Past or present ileostomy or colostomy Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, efalizumab, and tofactinib) History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
GZA Ziekenhuizen - Campus Sint-Vincentius
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
Imeldaziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
CHU St Pierre (St Pierre)
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel; Neurology
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc; Pharmacy
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint Elisabeth Herentals
City
Herentals
ZIP/Postal Code
2200
Country
Belgium
Facility Name
University of Calgary; Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Guelph GI & Surgery Clinic
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 3R3
Country
Canada
Facility Name
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
City
Kladno
ZIP/Postal Code
272 59
Country
Czechia
Facility Name
Mestska Nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
Facility Name
Pardubicka krajska nemocnice, a.s.
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
ISCARE a.s.
City
Praha 7
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Krajska nemocnice T. Bati, a.s.
City
Zlin
ZIP/Postal Code
76001
Country
Czechia
Facility Name
CHU de Caen - Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Tours - Hôpital Trousseau
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
CHU Clermont Ferrand - Hôtel Dieu
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hôpital Beaujon
City
Clichy cedex
ZIP/Postal Code
92110
Country
France
Facility Name
CHU Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nice - Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
DRK Kliniken Berlin Westend
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Krankenhaus Waldfriede e. V.
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Gastroenterologie Eppendorfer Baum
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Universitätsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
City
Budapest
ZIP/Postal Code
H-1077
Country
Hungary
Facility Name
Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Markhot Ferenc Oktato Korhaz es Rendelointezet
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Asst Fatebenefratelli Sacco (Fatebenefratelli)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
City
Milano
State/Province
Lombardia
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
I.R.C.C.S Policlinico San Donato
City
San Donato Milanese (MI)
State/Province
Lombardia
ZIP/Postal Code
20097
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
City
San Giovanni Rotondo
State/Province
Lombardia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
Azienda Ospedaliera Di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam Univ. Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13605
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Centre; CHA university
City
Seongnam
ZIP/Postal Code
13520
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon City
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Suwon-si,
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-Si
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Amsterdam UMC Location VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amsterdam UMC Location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Radboudumc
City
NL -nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Akershus universitetssykehus HF
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Hospital da Senhora da Oliveira Guimarães
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Institutul Clinic Fundeni Bucuresti
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucharest
ZIP/Postal Code
772202
Country
Romania
Facility Name
S.C MedLife S.A
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Centrul Medical Unirea SRL
City
Bucuresti
ZIP/Postal Code
040055
Country
Romania
Facility Name
Spitalul Clinic Judetean Mures
City
Targu Mures
ZIP/Postal Code
540103
Country
Romania
Facility Name
Centrul de Gastroenterologie Dr. Goldis
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Netcare Universitas Private Hospital
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Dr MJ Prins Practice
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Dr Corne Kruger Inc.
City
Cape Town
ZIP/Postal Code
7550
Country
South Africa
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Ferrol
City
Ferrol
State/Province
LA Coruña
ZIP/Postal Code
15405
Country
Spain
Facility Name
Fundacion Hospital de Alcorcon; Servicio de Digestivo
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Centro Médico Teknon
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Danderyds Sjukhus AB
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Inselspital-Universitaetsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Name
St Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 9NU
Country
United Kingdom
Facility Name
Fairfield General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
Citations:
PubMed Identifier
34798038
Citation
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.
Results Reference
derived
PubMed Identifier
32445184
Citation
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.
Results Reference
derived

Learn more about this trial

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

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