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A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors (LAUREL)

Primary Purpose

Colitis, Ulcerative

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

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of ulcerative colitis (UC) established at least 3 months prior to Day 1 by clinical and endoscopic evidence
  • Moderately to severely active UC as determined by an MCS of 6-12 with an endoscopic subscore greater than or equal to (≥)2 as determined by the central reading procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding subscore ≥1, and a stool frequency subscore ≥1 during the screening period (prior to Day 1)
  • Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening, 4-16 days prior to Day 1
  • Naive to treatment with any anti-TNF therapy
  • Participants must have had an inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
  • Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
  • Use of highly effective contraception
  • Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, 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
  • Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol
  • Any prior treatment with anti-adhesion molecules (such as mucosal addressin cell adhesion molecule [MAdCAM-1])
  • Any prior treatment with rituximab
  • Any treatment with tofacitinib during screening
  • Cogenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
  • Evidence of or treatment for Clostridium difficile within 60 days prior to Day 1 or other intestinal pathogens within 30 days prior to Day 1
  • History of recurrent opportunistic infections and/or severe disseminated viral infections
  • History of organ transplant
  • Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
  • Received a live attenuated vaccine within 4 weeks prior to Day 1

Sites / Locations

  • University of California, Irvine Medical Center
  • Clinical Applications Laboratories, Inc.
  • University of California at San Francisco
  • Ventura Clinical Trials
  • Peak Gastroenterology Associates; Gastroenterology
  • Clinical Research of the Rockies
  • West Central Gastroenterology d/b/a Gastro Florida
  • IMIC, Inc
  • Regenerate Clinical Trials
  • Advanced Research Institute, Inc.
  • Shafran Gastroenterology Center
  • Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
  • Southwest Gastroenterology
  • Aquiant Research
  • Louisiana Research Center, LLC
  • Commonwealth Clinical Studies
  • Henry Ford Health System
  • Center for Digestive Health
  • University of Minnesota
  • University of Mississippi Medical Center
  • Ehrhardt Clinical Research, LLC
  • Manhattan Clinical Research
  • Weill Cornell Medical College-New York Presbyterian Hospital
  • Asheville Gastroenterology Associates, P.A.
  • UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders
  • Kinston Medical Specialists
  • Texas Digestive Disease Consultants - Dallas
  • Texas Digestive Disease Consultants - Southlake
  • Digestive Health Specialists of Tyler
  • Ericksen Research and Development
  • University of Utah School of Medicine
  • McGuire Research Institute; Gastroenterology
  • Northwest Gastroenterology Associates
  • Hospital Universitario Walter Cantidio - UFC
  • Centro Digestivo de Curitiba
  • Hospital Moinhos de Vento
  • CECIP - Centro de Estudos Clínicos do Interior Paulista
  • Pesquisare Saúde Sociedade Simples
  • Hospital Estadual Mario Covas
  • Hospital Sírio-Libanês
  • Hospital do Servidor Público Estadual/HSPE-SP
  • Pacific Gastroenterology Associates
  • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
  • LHSC - University Hospital; Movement Disorders Program
  • London Health Sciences Centre Victoria Hospital; Research Pharmacy
  • Mount Sinai Hospital
  • Toronto Digestive Disease Associates
  • Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
  • Hepato-Gastroenterologie HK, s.r.o.
  • Nemocnice Na Bulovce
  • Alborg Universitets Hospital
  • Herlev og Gentofte Hospital
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
  • Ärztezentrum Ellwangen; Gemeinschaftspraxis
  • Klinik Johann Wolfgang von Goethe Uni
  • Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
  • Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
  • Medizinisches Zentrum Klinikum Lueneburg
  • Klinikum Mannheim GmbH Universitätsklinikum
  • DRC Gyogyszervizsgalo Kozpont Kft
  • Pannónia Klinika Magánorvosi
  • Debreceni Egyetem Klinikai Kozpont
  • Pest Megyei Flor Ferenc Korhaz
  • Csongrad Megyei Dr. Bugyi Istvan Korhaz
  • Osmania General Hospital
  • Deccan College of Medical Sciences and Allied Hospitals
  • Pushpawati Singhania Research Institute
  • Shree Giriraj Multispeciality Hospital
  • Nirmal Hospital
  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
  • M. S. Ramaiah Medical College and Hospital
  • Midas institute of Gastroenterology
  • Dayanand Medical College and Hospital
  • S. R. Kalla Memorial General Hospital
  • Kasturba Medical College & Hospital
  • Ruby Hall Clinic
  • King Edward Memorial Hospital Research Centre
  • Assaf Harofeh Medical Center
  • Bnei Zion Medical Center; Department of Internal Medicine B
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Holy Family Hospital
  • Ospedale Sandro Pertini
  • Fondazione Poliambulanza Istituto Ospedaliero
  • Ospedale di Circolo; Neuropsichiatria Infantile
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Centro Regiomontano de Estudios Clínicos Roma S.C.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Phylasis Clinicas Research S de RL de CV
  • Zespó Przychodni Specjalistycznych PRIMA
  • LexMedica Osrodek Badan Klinicznych
  • Fakultna nemocnica Nitra
  • Endomed, s.r.o.
  • Dr JP Wright Practice
  • Emmed Research
  • CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
  • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • Lviv Regional Clinical Hospital
  • A.Novak Transcarpathian Regional Clinical Hospital
  • Odessa regional clinical Hospital
  • M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
  • SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Open-Label Induction Phase: Etrolizumab

Double-Blind Maintenance Phase: Etrolizumab

Double-Blind Maintenance Phase: Placebo

Arm Description

All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.

Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.

Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.

Outcomes

Primary Outcome Measures

Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants With a Clinical Response at Week 10, as Determined by the Mayo Clinic Score (MCS)
MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. 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. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

Secondary Outcome Measures

Maintenance Phase: Percentage of Participants Who Maintained Clinical Remission at Week 62 Among Randomized Participants in Clinical Remission 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. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Maintenance Phase: Percentage of Participants in Clinical Remission at Week 62, 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. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission 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. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 62, as Determined by the MCS Endoscopic Subscore
MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.
Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 62, as Determined by the MCS Endoscopic Subscore
MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Endoscopic Remission is Endoscopy subscore = 0.
Maintenance Phase: Percentage of Participants With Histologic Remission at Week 62, as Determined by the Nancy Histological Index
Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy histological index of 0 or 1.
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 62 Among Participants 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. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 62 Among Participants 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. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Maintenance Phase: Change From Baseline to Week 62 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Maintenance Phase: Change From Baseline to Week 62 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional domain score ranges from 0-12, with a higher score indicating a worse disease state.
Maintenance Phase: Change From Baseline to Week 62 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ)
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 at Least One Adverse Event by Severity, According to 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 Serious Infection-Related Adverse Events
Number of Participants With Infection-Related Adverse Events by Severity, According to 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 Injection-Site Reactions by Severity, According to 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 by Severity, According to 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 Malignancies
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ)
As per protocol, the timepoints for each arm where more than a third of the samples were above the lower limit of quantitation (LLOQ), full summary statistics (Mean and Standard Deviation) were reported. For timepoints below the LLOQ, only the Median and Max were reported as a separate outcome measure below.
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ)
As per protocol, the timepoints for each arm where more than a third of the samples were below the LLOQ only the Median and Max were reported.

Full Information

First Posted
June 13, 2014
Last Updated
July 27, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02165215
Brief Title
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
Acronym
LAUREL
Official Title
Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 12, 2014 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
April 6, 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

5. Study Description

Brief Summary
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Open-Label Induction Phase: Etrolizumab
Arm Type
Experimental
Arm Description
All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.
Arm Title
Double-Blind Maintenance Phase: Etrolizumab
Arm Type
Experimental
Arm Description
Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.
Arm Title
Double-Blind Maintenance Phase: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Intervention Type
Drug
Intervention Name(s)
Etrolizumab
Other Intervention Name(s)
RG7413, RO5490261, PRO145223, rhuMAb Beta7
Intervention Description
Participants will receive 105 mg etrolizumab SC injection Q4W.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo (matched to etrolizumab) SC injection Q4W.
Primary Outcome Measure Information:
Title
Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants With a Clinical Response at Week 10, as Determined by the Mayo Clinic Score (MCS)
Description
MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. 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. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Time Frame
Week 62
Secondary Outcome Measure Information:
Title
Maintenance Phase: Percentage of Participants Who Maintained Clinical Remission at Week 62 Among Randomized Participants in Clinical Remission 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. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Time Frame
Week 62
Title
Maintenance Phase: Percentage of Participants in Clinical Remission at Week 62, 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. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Time Frame
Week 62
Title
Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission 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. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Time Frame
Week 62
Title
Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 62, as Determined by the MCS Endoscopic Subscore
Description
MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.
Time Frame
Baseline, Week 62
Title
Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 62, as Determined by the MCS Endoscopic Subscore
Description
MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Endoscopic Remission is Endoscopy subscore = 0.
Time Frame
Week 62
Title
Maintenance Phase: Percentage of Participants With Histologic Remission at Week 62, as Determined by the Nancy Histological Index
Description
Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy histological index of 0 or 1.
Time Frame
Week 62
Title
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 62 Among Participants 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. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Time Frame
Baseline, Week 62
Title
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 62 Among Participants 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. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Time Frame
Baseline, Week 62
Title
Maintenance Phase: Change From Baseline to Week 62 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire
Description
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Time Frame
Baseline, Week 62
Title
Maintenance Phase: Change From Baseline to Week 62 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Description
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional domain score ranges from 0-12, with a higher score indicating a worse disease state.
Time Frame
Baseline, Week 62
Title
Maintenance Phase: Change From Baseline to Week 62 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ)
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
Baseline, Week 62
Title
Number of Participants With at Least One Adverse Event by Severity, According to 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
From Baseline up to Week 74
Title
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Time Frame
From Baseline up to Week 74
Title
Number of Participants With Serious Infection-Related Adverse Events
Time Frame
From Baseline up to Week 74
Title
Number of Participants With Infection-Related Adverse Events by Severity, According to 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
From Baseline up to Week 74
Title
Number of Participants With Injection-Site Reactions by Severity, According to 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
From Baseline up to Week 74
Title
Number of Participants With Hypersensitivity Reaction Events by Severity, According to 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
From Baseline up to Week 74
Title
Number of Participants With Malignancies
Time Frame
From Baseline up to Week 74
Title
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Time Frame
Baseline, Weeks 4, 12, 24, 44, and 62, and and Early Termination/End of Safety Follow-Up (up to Week 74)
Title
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ)
Description
As per protocol, the timepoints for each arm where more than a third of the samples were above the lower limit of quantitation (LLOQ), full summary statistics (Mean and Standard Deviation) were reported. For timepoints below the LLOQ, only the Median and Max were reported as a separate outcome measure below.
Time Frame
Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62
Title
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ)
Description
As per protocol, the timepoints for each arm where more than a third of the samples were below the LLOQ only the Median and Max were reported.
Time Frame
Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62

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: Diagnosis of ulcerative colitis (UC) established at least 3 months prior to Day 1 by clinical and endoscopic evidence Moderately to severely active UC as determined by an MCS of 6-12 with an endoscopic subscore greater than or equal to (≥)2 as determined by the central reading procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding subscore ≥1, and a stool frequency subscore ≥1 during the screening period (prior to Day 1) Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening, 4-16 days prior to Day 1 Naive to treatment with any anti-TNF therapy Participants must have had an inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period Use of highly effective contraception Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening Exclusion Criteria: A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, 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 Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol Any prior treatment with anti-adhesion molecules (such as mucosal addressin cell adhesion molecule [MAdCAM-1]) Any prior treatment with rituximab Any treatment with tofacitinib during screening Cogenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent) Evidence of or treatment for Clostridium difficile within 60 days prior to Day 1 or other intestinal pathogens within 30 days prior to Day 1 History of recurrent opportunistic infections and/or severe disseminated viral infections History of organ transplant Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening Received a live attenuated vaccine within 4 weeks prior to Day 1
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
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical Applications Laboratories, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Peak Gastroenterology Associates; Gastroenterology
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Clinical Research of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Facility Name
IMIC, Inc
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Regenerate Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Aquiant Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Commonwealth Clinical Studies
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
Manhattan Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Texas Digestive Disease Consultants - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Ericksen Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
McGuire Research Institute; Gastroenterology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Northwest Gastroenterology Associates
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Hospital Universitario Walter Cantidio - UFC
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
Centro Digestivo de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80430-160
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
CECIP - Centro de Estudos Clínicos do Interior Paulista
City
Jaú
State/Province
SP
ZIP/Postal Code
17210-190
Country
Brazil
Facility Name
Pesquisare Saúde Sociedade Simples
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09080-000
Country
Brazil
Facility Name
Hospital Estadual Mario Covas
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09190-610
Country
Brazil
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Hospital do Servidor Público Estadual/HSPE-SP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Pacific Gastroenterology Associates
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
LHSC - University Hospital; Movement Disorders Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
London Health Sciences Centre Victoria Hospital; Research Pharmacy
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Digestive Disease Associates
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
180 01
Country
Czechia
Facility Name
Alborg Universitets Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Herlev og Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Ärztezentrum Ellwangen; Gemeinschaftspraxis
City
Ellwangen
ZIP/Postal Code
73479
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Medizinisches Zentrum Klinikum Lueneburg
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Klinikum Mannheim GmbH Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Pannónia Klinika Magánorvosi
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Osmania General Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500012
Country
India
Facility Name
Deccan College of Medical Sciences and Allied Hospitals
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500058
Country
India
Facility Name
Pushpawati Singhania Research Institute
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Shree Giriraj Multispeciality Hospital
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360005
Country
India
Facility Name
Nirmal Hospital
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
M. S. Ramaiah Medical College and Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Midas institute of Gastroenterology
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
S. R. Kalla Memorial General Hospital
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Kasturba Medical College & Hospital
City
Mangalore
ZIP/Postal Code
575001
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
ZIP/Postal Code
411 001
Country
India
Facility Name
King Edward Memorial Hospital Research Centre
City
Pune
ZIP/Postal Code
411011
Country
India
Facility Name
Assaf Harofeh Medical Center
City
Beer Yaacov
ZIP/Postal Code
6093000
Country
Israel
Facility Name
Bnei Zion Medical Center; Department of Internal Medicine B
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Holy Family Hospital
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Ospedale Sandro Pertini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00157
Country
Italy
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Ospedale di Circolo; Neuropsichiatria Infantile
City
Rho
State/Province
Lombardia
ZIP/Postal Code
20017
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Centro Regiomontano de Estudios Clínicos Roma S.C.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64610
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Phylasis Clinicas Research S de RL de CV
City
Estado de México
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Zespó Przychodni Specjalistycznych PRIMA
City
Warszawa
ZIP/Postal Code
02-018
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Endomed, s.r.o.
City
Vranov nad Topľou
ZIP/Postal Code
093 01
Country
Slovakia
Facility Name
Dr JP Wright Practice
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
City
Sumy
State/Province
Kharkiv Governorate
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
CI of Kyiv RC Kyiv Regional Clinical Hospital
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
A.Novak Transcarpathian Regional Clinical Hospital
City
Uzhgorod
State/Province
KIEV Governorate
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Odessa regional clinical Hospital
City
Odessa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
City
Uzhgorod
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34798037
Citation
Vermeire S, Lakatos PL, Ritter T, Hanauer S, Bressler B, Khanna R, Isaacs K, Shah S, Kadva A, Tyrrell H, Oh YS, Tole S, Chai A, Pulley J, Eden C, Zhang W, Feagan BG; LAUREL Study Group. Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):28-37. doi: 10.1016/S2468-1253(21)00295-8. 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 of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

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