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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118584
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 16, 2014
First Posted Date  ICMJE April 21, 2014
Last Update Posted Date March 20, 2023
Actual Study Start Date  ICMJE September 15, 2014
Estimated Primary Completion Date August 16, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) - Part 1 [ Time Frame: 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) ]
  • 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, 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) ]
  • Percentage of Participants With Adverse Events - Part 1 [ Time Frame: 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 ]
  • Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2 [ Time Frame: 104 weeks ]
  • Change From Baseline in pMCS at Year 9 [ Time Frame: Baseline, Year 9 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
Official Title  ICMJE An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: 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.
Other Names:
  • RG7413
  • RO5490261
  • PRO145223
  • rhuMAb Beta7
Study Arms  ICMJE
  • 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).
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 30, 2020)		 1822
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2014)		 2600
Estimated Study Completion Date  ICMJE August 16, 2025
Estimated Primary Completion Date August 16, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Philippines,   Sweden,   Vietnam
 
Administrative Information
NCT Number  ICMJE NCT02118584
Other Study ID Numbers  ICMJE GA28951
2013-004435-72 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2023

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