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Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

This study is currently recruiting participants.
Verified March 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT02118584
First Posted: April 21, 2014
Last Update Posted: March 17, 2017
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
April 16, 2014
April 21, 2014
March 17, 2017
September 30, 2014
November 30, 2019   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) - Part 1 [ Time Frame: Baseline up to 7 years (assessed at Baseline, Week 4, 8, 12 thereafter every 12 weeks up to 7 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study) ]
  • Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) - Part 1 [ Time Frame: Week 108 ]
  • Percentage of Participants With Endoscopic Remission [ Time Frame: Week 108 ]
  • Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab - Part 1 [ Time Frame: Baseline up to 7 years (assessed at Baseline, Week 12, 48, 108, at early withdrawal from treatment up to 7 years after first participant enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study) ]
  • Percentage of Participants With Adverse Events - Part 1 [ Time Frame: Baseline up to 7 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until the Sponsor's decision to terminate the study ]
  • Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2 [ Time Frame: 104 weeks ]
  • Change From Baseline in pMCS at Year 7 [ Time Frame: Baseline, Year 7 ]
  • Long-term efficacy as determined by partial Mayo Clinic Score (pMCS) [ Time Frame: Up to 7 years ]
  • Incidence of adverse events [ Time Frame: Up to 7 years ]
Complete list of historical versions of study NCT02118584 on ClinicalTrials.gov Archive Site
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Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
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 7 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Etrolizumab
Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 7 years or until either commercial availability or the Sponsor's decision to terminate the study.
Other Name: PRO145223, RO5490261
  • 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).
    Intervention: Drug: Etrolizumab
  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2625
November 30, 2019
November 30, 2019   (Final data collection date for primary outcome measure)

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.

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: GA28951 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
 
 
NCT02118584
GA28951
2013-004435-72 ( EudraCT Number )
Yes
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP