Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02118584




Registration number
NCT02118584
Ethics application status
Date submitted
16/04/2014
Date registered
21/04/2014
Date last updated
23/10/2024

Titles & IDs
Public title
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
Scientific title
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
Secondary ID [1] 0 0
2013-004435-72
Secondary ID [2] 0 0
GA28951
Universal Trial Number (UTN)
Trial acronym
COTTONWOOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrolizumab

Experimental: Part 1: Open-label Extension - Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE).

No intervention: Part 2: Safety Monitoring - All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks).


Treatment: Drugs: Etrolizumab
Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 9 years or until either commercial availability or the Sponsor's decision to terminate the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS)
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks
Primary outcome [2] 0 0
Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS)
Timepoint [2] 0 0
At OLE Week 108
Primary outcome [3] 0 0
Part 1: Percentage of Participants With Endoscopic Remission
Timepoint [3] 0 0
At OLE Week 108
Primary outcome [4] 0 0
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0]
Timepoint [4] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [5] 0 0
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [6] 0 0
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0
Timepoint [6] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [7] 0 0
Part 1: Number of Participants With Serious Infection Related AES
Timepoint [7] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [8] 0 0
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0
Timepoint [8] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [9] 0 0
Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation
Timepoint [9] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [10] 0 0
Part 1: Number of Participants With Malignancies
Timepoint [10] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [11] 0 0
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0
Timepoint [11] 0 0
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Primary outcome [12] 0 0
Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period
Timepoint [12] 0 0
From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks

Eligibility
Key inclusion criteria
Part 1 (Open-label Extension)

- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol

Part 2 (Safety Monitoring)

* Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
* Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
* Participants who transfer from Part 1 (OLE)
* Completion of the 12-week safety follow-up prior to entering.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1 (Open-label Extension)

* Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
* Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
* Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
* Any new, significant, uncontrolled condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2023
Sample size
Target
Accrual to date
Final
1822
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Mater Adult Hospital - Mackay
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
Launceston General Hospital; Gastroenterology Research - Launceston
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [11] 0 0
Footscray Hospital - Footscray
Recruitment hospital [12] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment hospital [13] 0 0
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville
Recruitment hospital [14] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4740 - Mackay
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
7250 - Launceston
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3011 - Footscray
Recruitment postcode(s) [12] 0 0
3144 - Malvern
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Argentina
State/province [23] 0 0
Cordoba
Country [24] 0 0
Argentina
State/province [24] 0 0
Rosario
Country [25] 0 0
Austria
State/province [25] 0 0
Salzburg
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Belgium
State/province [27] 0 0
Antwerpen
Country [28] 0 0
Belgium
State/province [28] 0 0
Bonheiden
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussels
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussel
Country [31] 0 0
Belgium
State/province [31] 0 0
Bruxelles
Country [32] 0 0
Belgium
State/province [32] 0 0
Gent
Country [33] 0 0
Belgium
State/province [33] 0 0
Herentals
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Roeselare
Country [36] 0 0
Brazil
State/province [36] 0 0
BA
Country [37] 0 0
Brazil
State/province [37] 0 0
CE
Country [38] 0 0
Brazil
State/province [38] 0 0
DF
Country [39] 0 0
Brazil
State/province [39] 0 0
GO
Country [40] 0 0
Brazil
State/province [40] 0 0
MG
Country [41] 0 0
Brazil
State/province [41] 0 0
PR
Country [42] 0 0
Brazil
State/province [42] 0 0
RJ
Country [43] 0 0
Brazil
State/province [43] 0 0
RS
Country [44] 0 0
Brazil
State/province [44] 0 0
SP
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Dupnitsa
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Pleven
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Ruse
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Sliven
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Sofia
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Stara Zagora
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Varna
Country [52] 0 0
Bulgaria
State/province [52] 0 0
Veliko Tarnovo
Country [53] 0 0
Canada
State/province [53] 0 0
Alberta
Country [54] 0 0
Canada
State/province [54] 0 0
British Columbia
Country [55] 0 0
Canada
State/province [55] 0 0
Nova Scotia
Country [56] 0 0
Canada
State/province [56] 0 0
Ontario
Country [57] 0 0
Canada
State/province [57] 0 0
Quebec
Country [58] 0 0
Canada
State/province [58] 0 0
Saskatchewan
Country [59] 0 0
Colombia
State/province [59] 0 0
Cali
Country [60] 0 0
Colombia
State/province [60] 0 0
Medellin
Country [61] 0 0
Croatia
State/province [61] 0 0
Osijek
Country [62] 0 0
Croatia
State/province [62] 0 0
Zagreb
Country [63] 0 0
Czechia
State/province [63] 0 0
Brno
Country [64] 0 0
Czechia
State/province [64] 0 0
Hradec Kralove
Country [65] 0 0
Czechia
State/province [65] 0 0
Kladno
Country [66] 0 0
Czechia
State/province [66] 0 0
Olomouc
Country [67] 0 0
Czechia
State/province [67] 0 0
Ostrava
Country [68] 0 0
Czechia
State/province [68] 0 0
Pardubice
Country [69] 0 0
Czechia
State/province [69] 0 0
Prague
Country [70] 0 0
Czechia
State/province [70] 0 0
Praha 7
Country [71] 0 0
Czechia
State/province [71] 0 0
Usti Nad Labem
Country [72] 0 0
Czechia
State/province [72] 0 0
Zlin
Country [73] 0 0
Denmark
State/province [73] 0 0
Hellerup
Country [74] 0 0
Denmark
State/province [74] 0 0
København Ø
Country [75] 0 0
Denmark
State/province [75] 0 0
Ålborg
Country [76] 0 0
Estonia
State/province [76] 0 0
Tallinn
Country [77] 0 0
Estonia
State/province [77] 0 0
Tartu
Country [78] 0 0
France
State/province [78] 0 0
Amiens
Country [79] 0 0
France
State/province [79] 0 0
Caen
Country [80] 0 0
France
State/province [80] 0 0
Chambray les Tours
Country [81] 0 0
France
State/province [81] 0 0
Clichy cedex
Country [82] 0 0
France
State/province [82] 0 0
Lille
Country [83] 0 0
France
State/province [83] 0 0
Montpellier
Country [84] 0 0
France
State/province [84] 0 0
Nice
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Pessac
Country [87] 0 0
France
State/province [87] 0 0
Pierre-Benite
Country [88] 0 0
France
State/province [88] 0 0
Saint Etienne
Country [89] 0 0
France
State/province [89] 0 0
Strasbourg
Country [90] 0 0
France
State/province [90] 0 0
Toulouse Cedex 09
Country [91] 0 0
France
State/province [91] 0 0
Vandoeuvre-les-nancy
Country [92] 0 0
Germany
State/province [92] 0 0
Berlin
Country [93] 0 0
Germany
State/province [93] 0 0
Bochum
Country [94] 0 0
Germany
State/province [94] 0 0
Erlangen
Country [95] 0 0
Germany
State/province [95] 0 0
Frankfurt
Country [96] 0 0
Germany
State/province [96] 0 0
Freiburg
Country [97] 0 0
Germany
State/province [97] 0 0
Halle
Country [98] 0 0
Germany
State/province [98] 0 0
Hamburg
Country [99] 0 0
Germany
State/province [99] 0 0
Hannover
Country [100] 0 0
Germany
State/province [100] 0 0
Jena
Country [101] 0 0
Germany
State/province [101] 0 0
Kiel
Country [102] 0 0
Germany
State/province [102] 0 0
Lueneburg
Country [103] 0 0
Germany
State/province [103] 0 0
Mannheim
Country [104] 0 0
Germany
State/province [104] 0 0
Muenster
Country [105] 0 0
Germany
State/province [105] 0 0
Schweinfurt
Country [106] 0 0
Germany
State/province [106] 0 0
Ulm
Country [107] 0 0
Greece
State/province [107] 0 0
Heraklio
Country [108] 0 0
Hong Kong
State/province [108] 0 0
Hong Kong
Country [109] 0 0
Hungary
State/province [109] 0 0
Balatonfured
Country [110] 0 0
Hungary
State/province [110] 0 0
Bekescsaba
Country [111] 0 0
Hungary
State/province [111] 0 0
Budapest
Country [112] 0 0
Hungary
State/province [112] 0 0
Debrecen
Country [113] 0 0
Hungary
State/province [113] 0 0
Eger
Country [114] 0 0
Hungary
State/province [114] 0 0
Gyor
Country [115] 0 0
Hungary
State/province [115] 0 0
Kistarcsa
Country [116] 0 0
Hungary
State/province [116] 0 0
Miskolc
Country [117] 0 0
Hungary
State/province [117] 0 0
Pecs
Country [118] 0 0
Hungary
State/province [118] 0 0
Szentes
Country [119] 0 0
Hungary
State/province [119] 0 0
Székesfehérvár
Country [120] 0 0
India
State/province [120] 0 0
Andhra Pradesh
Country [121] 0 0
India
State/province [121] 0 0
Gujarat
Country [122] 0 0
India
State/province [122] 0 0
Karnataka
Country [123] 0 0
India
State/province [123] 0 0
Maharashtra
Country [124] 0 0
India
State/province [124] 0 0
Punjab
Country [125] 0 0
India
State/province [125] 0 0
Rajasthan
Country [126] 0 0
India
State/province [126] 0 0
Pune
Country [127] 0 0
Israel
State/province [127] 0 0
Haifa
Country [128] 0 0
Israel
State/province [128] 0 0
Jerusalem
Country [129] 0 0
Israel
State/province [129] 0 0
Nazareth
Country [130] 0 0
Israel
State/province [130] 0 0
Petach Tiqwa
Country [131] 0 0
Israel
State/province [131] 0 0
Rehovot
Country [132] 0 0
Israel
State/province [132] 0 0
Rishon Lezion
Country [133] 0 0
Israel
State/province [133] 0 0
Tel Hashomer
Country [134] 0 0
Italy
State/province [134] 0 0
Emilia-Romagna
Country [135] 0 0
Italy
State/province [135] 0 0
Lazio
Country [136] 0 0
Italy
State/province [136] 0 0
Lombardia
Country [137] 0 0
Italy
State/province [137] 0 0
Piemonte
Country [138] 0 0
Italy
State/province [138] 0 0
Sicilia
Country [139] 0 0
Italy
State/province [139] 0 0
Toscana
Country [140] 0 0
Italy
State/province [140] 0 0
Veneto
Country [141] 0 0
Korea, Republic of
State/province [141] 0 0
Busan
Country [142] 0 0
Korea, Republic of
State/province [142] 0 0
Daegu
Country [143] 0 0
Korea, Republic of
State/province [143] 0 0
Gyeonggi-do
Country [144] 0 0
Korea, Republic of
State/province [144] 0 0
Seongnam-si
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Seongnam
Country [146] 0 0
Korea, Republic of
State/province [146] 0 0
Seoul
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Suwon City
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Suwon
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Wonju-si
Country [150] 0 0
Latvia
State/province [150] 0 0
Daugavpils
Country [151] 0 0
Latvia
State/province [151] 0 0
R?ga
Country [152] 0 0
Lithuania
State/province [152] 0 0
Kaunas
Country [153] 0 0
Lithuania
State/province [153] 0 0
Klaipeda
Country [154] 0 0
Lithuania
State/province [154] 0 0
Vilnius
Country [155] 0 0
Malaysia
State/province [155] 0 0
FED. Territory OF Kuala Lumpur
Country [156] 0 0
Malaysia
State/province [156] 0 0
Pahang
Country [157] 0 0
Malaysia
State/province [157] 0 0
Kota Bahru
Country [158] 0 0
Mexico
State/province [158] 0 0
Jalisco
Country [159] 0 0
Mexico
State/province [159] 0 0
Nuevo LEON
Country [160] 0 0
Mexico
State/province [160] 0 0
Cuautitlán Izcalli
Country [161] 0 0
Netherlands
State/province [161] 0 0
Amsterdam
Country [162] 0 0
Netherlands
State/province [162] 0 0
NL -nijmegen
Country [163] 0 0
New Zealand
State/province [163] 0 0
Auckland
Country [164] 0 0
New Zealand
State/province [164] 0 0
Dunedin
Country [165] 0 0
New Zealand
State/province [165] 0 0
Hamilton
Country [166] 0 0
New Zealand
State/province [166] 0 0
Takapuna
Country [167] 0 0
New Zealand
State/province [167] 0 0
Tauranga
Country [168] 0 0
Norway
State/province [168] 0 0
Lørenskog
Country [169] 0 0
Poland
State/province [169] 0 0
?ód?
Country [170] 0 0
Poland
State/province [170] 0 0
Bydgoszcz
Country [171] 0 0
Poland
State/province [171] 0 0
Chojnice
Country [172] 0 0
Poland
State/province [172] 0 0
Cz?stochowa
Country [173] 0 0
Poland
State/province [173] 0 0
Gdansk
Country [174] 0 0
Poland
State/province [174] 0 0
Katowice
Country [175] 0 0
Poland
State/province [175] 0 0
Krakow
Country [176] 0 0
Poland
State/province [176] 0 0
Ksawerow
Country [177] 0 0
Poland
State/province [177] 0 0
Lublin
Country [178] 0 0
Poland
State/province [178] 0 0
Nowy Targ
Country [179] 0 0
Poland
State/province [179] 0 0
Olsztyn
Country [180] 0 0
Poland
State/province [180] 0 0
Pozna?
Country [181] 0 0
Poland
State/province [181] 0 0
Rzeszow
Country [182] 0 0
Poland
State/province [182] 0 0
Rzeszów
Country [183] 0 0
Poland
State/province [183] 0 0
Sopot
Country [184] 0 0
Poland
State/province [184] 0 0
Szczecin
Country [185] 0 0
Poland
State/province [185] 0 0
Warszawa
Country [186] 0 0
Poland
State/province [186] 0 0
Wroc?aw
Country [187] 0 0
Poland
State/province [187] 0 0
Wroclaw
Country [188] 0 0
Portugal
State/province [188] 0 0
Braga
Country [189] 0 0
Portugal
State/province [189] 0 0
Guimarães
Country [190] 0 0
Romania
State/province [190] 0 0
Bucharest
Country [191] 0 0
Romania
State/province [191] 0 0
Bucuresti
Country [192] 0 0
Romania
State/province [192] 0 0
Timisoara
Country [193] 0 0
Russian Federation
State/province [193] 0 0
Adygeja
Country [194] 0 0
Russian Federation
State/province [194] 0 0
Altaj
Country [195] 0 0
Russian Federation
State/province [195] 0 0
Leningrad
Country [196] 0 0
Russian Federation
State/province [196] 0 0
Moskovskaja Oblast
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Niznij Novgorod
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Rostov
Country [199] 0 0
Russian Federation
State/province [199] 0 0
Sankt Petersburg
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Vologda
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Voronez
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Irkutsk
Country [203] 0 0
Russian Federation
State/province [203] 0 0
Novosibirsk
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Omsk
Country [205] 0 0
Russian Federation
State/province [205] 0 0
Stavropol
Country [206] 0 0
Serbia
State/province [206] 0 0
Belgrade
Country [207] 0 0
Serbia
State/province [207] 0 0
Kragujevac
Country [208] 0 0
Serbia
State/province [208] 0 0
Zrenjanin
Country [209] 0 0
Singapore
State/province [209] 0 0
Singapore
Country [210] 0 0
Slovakia
State/province [210] 0 0
Banska Bystrica
Country [211] 0 0
Slovakia
State/province [211] 0 0
Humenné
Country [212] 0 0
Slovakia
State/province [212] 0 0
Košice
Country [213] 0 0
Slovakia
State/province [213] 0 0
Nitra
Country [214] 0 0
Slovakia
State/province [214] 0 0
Prešov
Country [215] 0 0
Slovakia
State/province [215] 0 0
Rimavská Sobota
Country [216] 0 0
Slovakia
State/province [216] 0 0
Šahy
Country [217] 0 0
South Africa
State/province [217] 0 0
Bloemfontein
Country [218] 0 0
South Africa
State/province [218] 0 0
Cape Town
Country [219] 0 0
South Africa
State/province [219] 0 0
Pretoria
Country [220] 0 0
Spain
State/province [220] 0 0
Barcelona
Country [221] 0 0
Spain
State/province [221] 0 0
Madrid
Country [222] 0 0
Spain
State/province [222] 0 0
Girona
Country [223] 0 0
Spain
State/province [223] 0 0
Valencia
Country [224] 0 0
Spain
State/province [224] 0 0
Zaragoza
Country [225] 0 0
Switzerland
State/province [225] 0 0
Bern
Country [226] 0 0
Turkey
State/province [226] 0 0
Ankara
Country [227] 0 0
Turkey
State/province [227] 0 0
Istanbul
Country [228] 0 0
Turkey
State/province [228] 0 0
Kocaeli
Country [229] 0 0
Ukraine
State/province [229] 0 0
Kharkiv Governorate
Country [230] 0 0
Ukraine
State/province [230] 0 0
KIEV Governorate
Country [231] 0 0
Ukraine
State/province [231] 0 0
Podolia Governorate
Country [232] 0 0
Ukraine
State/province [232] 0 0
Tavria Okruha
Country [233] 0 0
Ukraine
State/province [233] 0 0
Chernivtsi
Country [234] 0 0
Ukraine
State/province [234] 0 0
Dnipropetrovsk
Country [235] 0 0
Ukraine
State/province [235] 0 0
Kharkiv
Country [236] 0 0
Ukraine
State/province [236] 0 0
Kherson
Country [237] 0 0
Ukraine
State/province [237] 0 0
Kyiv
Country [238] 0 0
Ukraine
State/province [238] 0 0
Odessa
Country [239] 0 0
Ukraine
State/province [239] 0 0
Poltava
Country [240] 0 0
Ukraine
State/province [240] 0 0
Vinnytsia
Country [241] 0 0
Ukraine
State/province [241] 0 0
Zaporizhzhia
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Cambridge
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Coventry
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Exeter
Country [245] 0 0
United Kingdom
State/province [245] 0 0
Leeds
Country [246] 0 0
United Kingdom
State/province [246] 0 0
London
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Manchester
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Newcastle upon Tyne
Country [249] 0 0
United Kingdom
State/province [249] 0 0
Nottingham
Country [250] 0 0
United Kingdom
State/province [250] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 \[NCT01461317\]) or the Phase III studies (GA28948 \[NCT02163759\], GA28949 \[NCT02171429\], GA28950 \[NCT02100696\], GA29102 \[NCT02165215\], and GA29103 \[NCT02136069\]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
Trial website
https://clinicaltrials.gov/study/NCT02118584
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02118584