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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02118584




Registration number
NCT02118584
Ethics application status
Date submitted
16/04/2014
Date registered
21/04/2014
Date last updated
1/11/2023

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
Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) - Part 1
Timepoint [1] 0 0
Baseline up to 9 years (assessed at Baseline, Week 4, 8, 12 thereafter every 12 weeks up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)
Primary outcome [2] 0 0
Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) - Part 1
Timepoint [2] 0 0
Week 108
Primary outcome [3] 0 0
Percentage of Participants With Endoscopic Remission
Timepoint [3] 0 0
Week 108
Primary outcome [4] 0 0
Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab - Part 1
Timepoint [4] 0 0
Baseline, Week 12, every 48 weeks, week 108, at early withdrawal from treatment up to 9 years after first participant enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)
Primary outcome [5] 0 0
Percentage of Participants With Adverse Events - Part 1
Timepoint [5] 0 0
Baseline up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until the Sponsor's decision to terminate the study
Primary outcome [6] 0 0
Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2
Timepoint [6] 0 0
104 weeks
Primary outcome [7] 0 0
Change From Baseline in pMCS at Year 9
Timepoint [7] 0 0
Baseline, Year 9

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
N/A
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
Terminated
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
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Royal Brisbane and Women's Hospital - Herston
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Mater Adult Hospital - Mackay
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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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
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St Vincent's Hospital Melbourne - Fitzroy
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Footscray Hospital - Footscray
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St Frances Xavier Cabrini Hospital - Malvern
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Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville
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Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
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2139 - Concord
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4029 - Herston
Recruitment postcode(s) [4] 0 0
4740 - Mackay
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4102 - Woolloongabba
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5000 - Adelaide
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5042 - Bedford Park
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7250 - Launceston
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3168 - Clayton
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3065 - Fitzroy
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3011 - Footscray
Recruitment postcode(s) [12] 0 0
3144 - Malvern
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3050 - Parkville
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
Recruitment outside Australia
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Halle
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Eger
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Gyor
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Kistarcsa
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Nazareth
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Petach Tiqwa
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Rehovot
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Israel
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Tel Hashomer
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Veneto
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeonggi-do
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Seongnam-si
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Korea, Republic of
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Seongnam
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Seoul
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Suwon City
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Bucuresti
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Leningrad
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Novosibirsk
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Omsk
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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/ct2/show/NCT02118584
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02118584