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LAUREL: 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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02165215
Collaborator
(none)
359
Enrollment
104
Locations
3
Arms
67.8
Actual Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
359 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 12, 2014
Actual Primary Completion Date :
Apr 6, 2020
Actual Study Completion Date :
Apr 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open-Label Induction Phase: Etrolizumab

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

Drug: Etrolizumab
Participants will receive 105 mg etrolizumab SC injection Q4W.
Other Names:
  • RG7413
  • RO5490261
  • PRO145223
  • rhuMAb Beta7

    		•
    Experimental: Double-Blind Maintenance Phase: Etrolizumab

    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.

    Drug: Etrolizumab
    Participants will receive 105 mg etrolizumab SC injection Q4W.
    Other Names:
  • RG7413
  • RO5490261
  • PRO145223
  • rhuMAb Beta7

    		•
    Placebo Comparator: Double-Blind Maintenance Phase: Placebo

    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.

    Drug: Placebo
    Participants will receive placebo (matched to etrolizumab) SC injection Q4W.

    Outcome Measures

    Primary Outcome Measures

    1. 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) [Week 62]

      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

    1. 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 [Week 62]

      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.

    2. Maintenance Phase: Percentage of Participants in Clinical Remission at Week 62, as Determined by the MCS [Week 62]

      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.

    3. Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission at Week 10, as Determined by the MCS [Week 62]

      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.

    4. 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 [Baseline, Week 62]

      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.

    5. Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 62, as Determined by the MCS Endoscopic Subscore [Week 62]

      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.

    6. Maintenance Phase: Percentage of Participants With Histologic Remission at Week 62, as Determined by the Nancy Histological Index [Week 62]

      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.

    7. 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 [Baseline, Week 62]

      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.

    8. 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 [Baseline, Week 62]

      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.

    9. 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 [Baseline, Week 62]

      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.

    10. Maintenance Phase: Change From Baseline to Week 62 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire [Baseline, Week 62]

      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.

    11. 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) [Baseline, Week 62]

      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.

    12. 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) [From Baseline up to Week 74]

      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.

    13. Number of Participants With Adverse Events Leading to Study Drug Discontinuation [From Baseline up to Week 74]

    14. Number of Participants With Serious Infection-Related Adverse Events [From Baseline up to Week 74]

    15. Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 [From Baseline up to Week 74]

      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.

    16. Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 [From Baseline up to Week 74]

      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.

    17. Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 [From Baseline up to Week 74]

      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.

    18. Number of Participants With Malignancies [From Baseline up to Week 74]

    19. Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [Baseline, Weeks 4, 12, 24, 44, and 62, and and Early Termination/End of Safety Follow-Up (up to Week 74)]

    20. Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) [Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62]

      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.

    21. Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ) [Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Irvine Medical Center Orange California United States 92868
    2 Clinical Applications Laboratories, Inc. San Diego California United States 92103
    3 University of California at San Francisco San Francisco California United States 94115
    4 Ventura Clinical Trials Ventura California United States 93003
    5 Peak Gastroenterology Associates; Gastroenterology Colorado Springs Colorado United States 80907
    6 Clinical Research of the Rockies Lafayette Colorado United States 80026
    7 West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida United States 33762
    8 IMIC, Inc Miami Beach Florida United States 33140
    9 Regenerate Clinical Trials Miami Florida United States 33155
    10 Advanced Research Institute, Inc. Trinity Florida United States 34655
    11 Shafran Gastroenterology Center Winter Park Florida United States 32789
    12 Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology Chicago Illinois United States 60611
    13 Southwest Gastroenterology Oak Lawn Illinois United States 60453
    14 Aquiant Research New Albany Indiana United States 47150
    15 Louisiana Research Center, LLC Shreveport Louisiana United States
    16 Commonwealth Clinical Studies Brockton Massachusetts United States 02302
    17 Henry Ford Health System Detroit Michigan United States 48202
    18 Center for Digestive Health Troy Michigan United States 48098
    19 University of Minnesota Minneapolis Minnesota United States 55455
    20 University of Mississippi Medical Center Jackson Mississippi United States 39216
    21 Ehrhardt Clinical Research, LLC Belton Missouri United States 64012
    22 Manhattan Clinical Research New York New York United States 10016
    23 Weill Cornell Medical College-New York Presbyterian Hospital New York New York United States 10021
    24 Asheville Gastroenterology Associates, P.A. Asheville North Carolina United States 28801
    25 UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders Chapel Hill North Carolina United States 27599
    26 Kinston Medical Specialists Kinston North Carolina United States 28501
    27 Texas Digestive Disease Consultants - Dallas Dallas Texas United States 75231
    28 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
    29 Digestive Health Specialists of Tyler Tyler Texas United States 75701
    30 Ericksen Research and Development Clinton Utah United States 84015
    31 University of Utah School of Medicine Salt Lake City Utah United States 84132
    32 McGuire Research Institute; Gastroenterology Richmond Virginia United States 23249
    33 Northwest Gastroenterology Associates Bellevue Washington United States 98004
    34 Hospital Universitario Walter Cantidio - UFC Fortaleza CE Brazil 60430-370
    35 Centro Digestivo de Curitiba Curitiba PR Brazil 80430-160
    36 Hospital Moinhos de Vento Porto Alegre RS Brazil 90035-001
    37 CECIP - Centro de Estudos Clínicos do Interior Paulista Jaú SP Brazil 17210-190
    38 Pesquisare Saúde Sociedade Simples Santo Andre SP Brazil 09080-000
    39 Hospital Estadual Mario Covas Santo Andre SP Brazil 09190-610
    40 Hospital Sírio-Libanês Sao Paulo SP Brazil 01308-050
    41 Hospital do Servidor Público Estadual/HSPE-SP São Paulo SP Brazil 04039-901
    42 Pacific Gastroenterology Associates Vancouver British Columbia Canada V6Z 2K5
    43 Queen Elizabeth II Health Sciences Centre; Gastroenterology Research Halifax Nova Scotia Canada B3H 1V7
    44 LHSC - University Hospital; Movement Disorders Program London Ontario Canada N6A 5A5
    45 London Health Sciences Centre Victoria Hospital; Research Pharmacy London Ontario Canada N6A 5W9
    46 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5
    47 Toronto Digestive Disease Associates Vaughan Ontario Canada L4L 4Y7
    48 Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika Brno Czechia 65691
    49 Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove Czechia 500 12
    50 Nemocnice Na Bulovce Prague Czechia 180 01
    51 Alborg Universitets Hospital Aalborg Denmark 9100
    52 Herlev og Gentofte Hospital Herlev Denmark 2730
    53 Charite Universitaetsmedizin Berlin - Campus Charite Mitte Berlin Germany 10117
    54 Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH Bochum Germany 44789
    55 Ärztezentrum Ellwangen; Gemeinschaftspraxis Ellwangen Germany 73479
    56 Klinik Johann Wolfgang von Goethe Uni Frankfurt Germany 60590
    57 Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie Hannover Germany 30625
    58 Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena Jena Germany 07740
    59 Medizinisches Zentrum Klinikum Lueneburg Lueneburg Germany 21339
    60 Klinikum Mannheim GmbH Universitätsklinikum Mannheim Germany 68167
    61 DRC Gyogyszervizsgalo Kozpont Kft Balatonfured Hungary 8230
    62 Pannónia Klinika Magánorvosi Budapest Hungary 1136
    63 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
    64 Pest Megyei Flor Ferenc Korhaz Kistarcsa Hungary 2143
    65 Csongrad Megyei Dr. Bugyi Istvan Korhaz Szentes Hungary 6600
    66 Osmania General Hospital Hyderabad Andhra Pradesh India 500012
    67 Deccan College of Medical Sciences and Allied Hospitals Hyderabad Andhra Pradesh India 500058
    68 Pushpawati Singhania Research Institute New Delhi Delhi India 110017
    69 Shree Giriraj Multispeciality Hospital Rajkot Gujarat India 360005
    70 Nirmal Hospital Surat Gujarat India 395002
    71 K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre Belgaum Karnataka India 590010
    72 M. S. Ramaiah Medical College and Hospital Bengaluru Karnataka India 560054
    73 Midas institute of Gastroenterology Nagpur Maharashtra India 440012
    74 Dayanand Medical College and Hospital Ludhiana Punjab India 141001
    75 S. R. Kalla Memorial General Hospital Jaipur India 302001
    76 Kasturba Medical College & Hospital Mangalore India 575001
    77 Ruby Hall Clinic Pune India 411 001
    78 King Edward Memorial Hospital Research Centre Pune India 411011
    79 Assaf Harofeh Medical Center Beer Yaacov Israel 6093000
    80 Bnei Zion Medical Center; Department of Internal Medicine B Haifa Israel 31048
    81 Shaare Zedek Medical Center Jerusalem Israel 9103102
    82 Hadassah University Hospital - Ein Kerem Jerusalem Israel 9112001
    83 Holy Family Hospital Nazareth Israel 16100
    84 Ospedale Sandro Pertini Roma Lazio Italy 00157
    85 Fondazione Poliambulanza Istituto Ospedaliero Brescia Lombardia Italy 25124
    86 Ospedale di Circolo; Neuropsichiatria Infantile Rho Lombardia Italy 20017
    87 Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Sicilia Italy 90127
    88 Centro Regiomontano de Estudios Clínicos Roma S.C. Monterrey Nuevo LEON Mexico 64610
    89 Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Durango Mexico 34000
    90 Phylasis Clinicas Research S de RL de CV Estado de México Mexico 54769
    91 Zespó Przychodni Specjalistycznych PRIMA Warszawa Poland 02-018
    92 LexMedica Osrodek Badan Klinicznych Wroclaw Poland 53-114
    93 Fakultna nemocnica Nitra Nitra Slovakia 950 01
    94 Endomed, s.r.o. Vranov nad Topľou Slovakia 093 01
    95 Dr JP Wright Practice Cape Town South Africa 7708
    96 Emmed Research Pretoria South Africa 0002
    97 CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI Sumy Kharkiv Governorate Ukraine 40022
    98 CI of Kyiv RC Kyiv Regional Clinical Hospital Kyiv KIEV Governorate Ukraine 04107
    99 Lviv Regional Clinical Hospital Lviv KIEV Governorate Ukraine 79010
    100 A.Novak Transcarpathian Regional Clinical Hospital Uzhgorod KIEV Governorate Ukraine 88018
    101 Odessa regional clinical Hospital Odessa Ukraine 65117
    102 M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA Poltava Ukraine 36011
    103 SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU Uzhgorod Ukraine 88009
    104 M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia Ukraine 21018

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02165215
    Other Study ID Numbers:
    • GA29102
    • 2013-004280-31
    First Posted:
    Jun 17, 2014
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Etrolizumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 359 participants were enrolled into the OLI phase of the study. A total of 210 participants were randomized into the Maintenance phase and received either Etrolizumab or Placebo.
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Period Title: Induction Phase
    STARTED 359 0 0
    Dosed 358 0 0
    COMPLETED 336 0 0
    NOT COMPLETED 23 0 0
    Period Title: Induction Phase
    STARTED 0 108 106
    Dosed 0 108 102
    COMPLETED 0 96 101
    NOT COMPLETED 0 12 5

    Baseline Characteristics

    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo Total
    Arm/Group 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. Total of all reporting groups
    Overall Participants 359 108 106 573
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.3
    (13.7)
    39.2
    (13.5)
    38.7
    (13.6)
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    39.2
    (13.9)
    39.2
    (13.9)
    Sex: Female, Male (Count of Participants)
    Female
    48
    13.4%
    54
    50%
    102
    96.2%
    Male
    60
    16.7%
    52
    48.1%
    112
    105.7%
    Sex: Female, Male (Count of Participants)
    Female
    156
    43.5%
    156
    144.4%
    Male
    203
    56.5%
    203
    188%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    0.6%
    2
    1.9%
    4
    3.8%
    Asian
    21
    5.8%
    13
    12%
    34
    32.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    0.6%
    6
    5.6%
    8
    7.5%
    White
    79
    22%
    78
    72.2%
    157
    148.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    4
    1.1%
    7
    6.5%
    11
    10.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    5
    1.4%
    5
    4.6%
    Asian
    58
    16.2%
    58
    53.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    Black or African American
    13
    3.6%
    13
    12%
    White
    269
    74.9%
    269
    249.1%
    More than one race
    0
    0%
    0
    0%
    Unknown or Not Reported
    14
    3.9%
    14
    13%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that received an intervention
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 108 102
    Number [percentage of participants]
    29.6
    8.2%
    20.6
    19.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1942
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in response rates
    Estimated Value 7.7
    Confidence Interval (2-Sided) 95%
    -4.2 to 19.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that had Clinical Remission at Week 10
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 45 44
    Number [percentage of participants]
    44.4
    12.4%
    27.3
    25.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1524
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in remission rates
    Estimated Value 14.6
    Confidence Interval (2-Sided) 95%
    -5.55 to 33.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that received an intervention
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 108 102
    Number [percentage of participants]
    30.6
    8.5%
    20.6
    19.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1466
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in remission rates
    Estimated Value 8.7
    Confidence Interval (2-Sided) 95%
    -3.26 to 20.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that had Remission at Week 10
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 40 41
    Number [percentage of participants]
    40.0
    11.1%
    26.8
    24.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3083
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in remission rates
    Estimated Value 10.9
    Confidence Interval () 95%
    -9.72 to 30.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that received an intervention
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 108 102
    Number [percentage of participants]
    38.0
    10.6%
    22.5
    20.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0235
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in response rates
    Estimated Value 14.4
    Confidence Interval (2-Sided) 95%
    1.84 to 26.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that received an intervention
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 108 102
    Number [percentage of participants]
    30.6
    8.5%
    16.7
    15.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0293
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in remission rates
    Estimated Value 12.8
    Confidence Interval () 95%
    1.13 to 23.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that were evaluated using the Nancy histological index (enrolled after the latest protocol amendment)
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 85 78
    Number [percentage of participants]
    42.4
    11.8%
    21.8
    20.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in remission rates
    Estimated Value 19.8
    Confidence Interval (2-Sided) 95%
    5.16 to 33.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study receiving Corticosteroids at baseline
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 55 50
    Number [percentage of participants]
    18.2
    5.1%
    8.0
    7.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1415
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in remission rates
    Estimated Value 9.9
    Confidence Interval () 95%
    -4.47 to 23.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study receiving Corticosteroids at baseline
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 55 50
    Number [percentage of participants]
    18.2
    5.1%
    8.0
    7.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1415
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Adjusted difference in remission rates
    Estimated Value 9.9
    Confidence Interval () 95%
    -4.47 to 23.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that completed a baseline and at least 1 post-baseline questionnaire
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 68 73
    Least Squares Mean (Standard Error) [score on a scale]
    -9.6
    (0.8)
    -6.7
    (0.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0266
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Difference in Least Square Means
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -5.3 to -0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that completed a baseline and at least 1 post-baseline questionnaire
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 68 73
    Least Squares Mean (Standard Error) [score on a scale]
    -3.0
    (0.3)
    -1.8
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0175
    Comments p-value has not been adjusted for multiplicity
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Difference in Least Square Means
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.2 to -0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants in the Maintenance phase of the study that received an intervention
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 108 102
    Least Squares Mean (Standard Error) [scores on a scale]
    66.9
    (3.39)
    64.8
    (3.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Double-Blind Maintenance Phase: Etrolizumab, Double-Blind Maintenance Phase: Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6331
    Comments p-value has not been adjusted for multiplicity
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Mean
    Estimated Value 2.1
    Confidence Interval (2-Sided) 95%
    -6.6 to 10.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All participants that received an intervention
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 358 108 102
    Grade 1
    95
    26.5%
    24
    22.2%
    23
    21.7%
    Grade 2
    58
    16.2%
    30
    27.8%
    44
    41.5%
    Grade 3
    24
    6.7%
    14
    13%
    15
    14.2%
    Grade 4
    3
    0.8%
    2
    1.9%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    14. Secondary Outcome
    Title Number of Participants With Adverse Events Leading to Study Drug Discontinuation
    Description
    Time Frame From Baseline up to Week 74

    Outcome Measure Data

    Analysis Population Description
    All participants that received an intervention
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 358 108 102
    Number [participants]
    9
    2.5%
    5
    4.6%
    9
    8.5%
    15. Secondary Outcome
    Title Number of Participants With Serious Infection-Related Adverse Events
    Description
    Time Frame From Baseline up to Week 74

    Outcome Measure Data

    Analysis Population Description
    All participants that received an intervention
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 358 108 102
    Number [participants]
    6
    1.7%
    2
    1.9%
    2
    1.9%
    16. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All participants that received an intervention
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 358 108 102
    Grade 1
    39
    10.9%
    18
    16.7%
    22
    20.8%
    Grade 2
    21
    5.8%
    17
    15.7%
    10
    9.4%
    Grade 3
    6
    1.7%
    1
    0.9%
    2
    1.9%
    Grade 4
    0
    0%
    1
    0.9%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    17. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All participants that received an intervention
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 358 108 102
    Grade 1
    8
    2.2%
    4
    3.7%
    3
    2.8%
    Grade 2
    0
    0%
    0
    0%
    0
    0%
    Grade 3
    0
    0%
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    18. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All participants that received an intervention
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 358 108 102
    Grade 1
    0
    0%
    0
    0%
    0
    0%
    Grade 2
    1
    0.3%
    0
    0%
    0
    0%
    Grade 3
    0
    0%
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    19. Secondary Outcome
    Title Number of Participants With Malignancies
    Description
    Time Frame From Baseline up to Week 74

    Outcome Measure Data

    Analysis Population Description
    All participants that received an intervention
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 358 108 102
    Number [participants]
    0
    0%
    2
    1.9%
    1
    0.9%
    20. Secondary Outcome
    Title Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
    Description
    Time Frame Baseline, Weeks 4, 12, 24, 44, and 62, and and Early Termination/End of Safety Follow-Up (up to Week 74)

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result from at least one sample.
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 337 108 102
    Number [participants]
    62
    17.3%
    35
    32.4%
    33
    31.1%
    21. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data.
    Arm/Group Title Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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. 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.
    Measure Participants 105 100
    Week 12
    7.66
    (4.21)
    7.63
    (3.67)
    Week 24
    10
    (4.86)
    Week 44
    10
    (4.88)
    Week 62
    15.4
    (7.46)
    22. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug, had evaluable PK data and were part of the timepoint that had more than a third of samples below LLOQ.
    Arm/Group Title Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    Measure Participants 100
    Week 24
    0.0963
    Week 44
    0.0400
    Week 62
    0.0400

    Adverse Events

    Time Frame From Baseline up to Week 74
    Adverse Event Reporting Description
    Arm/Group Title Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Arm/Group 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.
    All Cause Mortality
    Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/358 (0%) 0/108 (0%) 0/102 (0%)
    Serious Adverse Events
    Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/358 (4.7%) 10/108 (9.3%) 8/102 (7.8%)
    Blood and lymphatic system disorders
    Anaemia 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Bone marrow failure 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Iron deficiency anaemia 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Cardiac disorders
    Myocardial infarction 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Gastrointestinal disorders
    Anal fistula 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Colitis ulcerative 6/358 (1.7%) 7 2/108 (1.9%) 2 2/102 (2%) 2
    Crohn's disease 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Diarrhoea haemorrhagic 0/358 (0%) 0 0/108 (0%) 0 1/102 (1%) 1
    Intestinal obstruction 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Intestinal perforation 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Pancreatitis 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    General disorders
    Systemic inflammatory response syndrome 0/358 (0%) 0 0/108 (0%) 0 1/102 (1%) 1
    Hepatobiliary disorders
    Bile duct stone 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Hepatitis 0/358 (0%) 0 0/108 (0%) 0 2/102 (2%) 2
    Infections and infestations
    Appendicitis 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Clostridium difficile colitis 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Hepatitis B 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Pulmonary tuberculosis 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Rectal abscess 1/358 (0.3%) 1 0/108 (0%) 0 1/102 (1%) 1
    Septic shock 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Upper respiratory tract infection 0/358 (0%) 0 0/108 (0%) 0 1/102 (1%) 1
    Urinary tract infection 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Investigations
    Blood creatine phosphokinase increased 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Musculoskeletal and connective tissue disorders
    Exostosis 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Osteoarthritis 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer metastatic 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Gallbladder cancer 0/358 (0%) 0 1/108 (0.9%) 1 0/102 (0%) 0
    Renal and urinary disorders
    Renal failure 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Pneumonitis 1/358 (0.3%) 1 0/108 (0%) 0 0/102 (0%) 0
    Pulmonary embolism 0/358 (0%) 0 0/108 (0%) 0 1/102 (1%) 1
    Vascular disorders
    Deep vein thrombosis 0/358 (0%) 0 0/108 (0%) 0 1/102 (1%) 1
    Other (Not Including Serious) Adverse Events
    Open-Label Induction Phase: Etrolizumab Double-Blind Maintenance Phase: Etrolizumab Double-Blind Maintenance Phase: Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 64/358 (17.9%) 30/108 (27.8%) 54/102 (52.9%)
    Gastrointestinal disorders
    Abdominal pain 1/358 (0.3%) 1 6/108 (5.6%) 9 9/102 (8.8%) 11
    Colitis ulcerative 24/358 (6.7%) 24 14/108 (13%) 16 34/102 (33.3%) 35
    Diarrhoea 5/358 (1.4%) 10 4/108 (3.7%) 4 8/102 (7.8%) 9
    General disorders
    Pyrexia 8/358 (2.2%) 9 0/108 (0%) 0 6/102 (5.9%) 6
    Infections and infestations
    Nasopharyngitis 22/358 (6.1%) 22 8/108 (7.4%) 10 3/102 (2.9%) 4
    Musculoskeletal and connective tissue disorders
    Arthralgia 9/358 (2.5%) 11 8/108 (7.4%) 10 11/102 (10.8%) 11

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800 821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02165215
    Other Study ID Numbers:
    • GA29102
    • 2013-004280-31
    First Posted:
    Jun 17, 2014
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Jul 1, 2021