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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
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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
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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
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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
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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
Recruitment postcode(s) [9] 0 0
3168 - Clayton
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3065 - Fitzroy
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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
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Jena
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Daegu
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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/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
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries



Summary Results

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