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Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (JUNIPER)

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ClinicalTrials.gov Identifier: NCT02403323
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE March 31, 2015
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE June 8, 2015
Estimated Primary Completion Date May 21, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time [ Time Frame: Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Number of Participants with Clinical Remission Over Time [ Time Frame: Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earlier (up to approximately 10 years) ]
    Clinical remission is defined by a loose/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain mean daily score ≤1 with no worsening in either subscore compared to baseline, averaged over 7 days prior to visit.
  • Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 [ Time Frame: Week 108 (or at early withdrawal, if prior to Week 108) ]
  • Part 1: Overall Number of Participants who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Number of Infection-Related Adverse Events per Patient-Year [ Time Frame: From Week 0 until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Overall Number of Participants who Develop Malignancies [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Number of Malignancies per Patient-Year [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years) ]
  • Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [ Time Frame: Weeks 0 and 12, and every 48 weeks thereafter until study completion or early withdrawal (up to approximately 10 years) ]
  • Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML) [ Time Frame: From end of safety follow-up until completion of 92-week safety monitoring in Part 2 (up to 92 weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
Open-label Extension Safety: Incidence of adverse events [ Time Frame: For up to 6.5 years after the first patient is enrolled into the study ]
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 Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Official Title  ICMJE An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Brief Summary This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE Drug: Etrolizumab
105 mg etrolizumab subcutaneous administration once every 4 weeks
Other Name: RG7413
Study Arms  ICMJE
  • Experimental: Part 1: Etrolizumab Open-Label Extension
    Participants will receive open-label treatment with etrolizumab once every 4 weeks until commercial availability in their country or sponsor's decision to terminate the study, whichever is earlier (up to approximately 10 years after the first patient is enrolled).
    Intervention: Drug: Etrolizumab
  • No Intervention: Part 2: Safety Monitoring
    Participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2015)
900
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2015)
1250
Estimated Study Completion Date  ICMJE May 21, 2026
Estimated Primary Completion Date May 21, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Part 1 Open-Label Extension:

  • Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

  • Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
  • Patients who transfer from Part 1
  • Completion of the 12-week safety follow-up period prior to entering

Exclusion Criteria:

Part 1 Open-Label Extension:

  • Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

  • No exclusion criteria
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: Reference Study ID Number: GA29145 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Luxembourg,   Mexico,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02403323
Other Study ID Numbers  ICMJE GA29145
2014-003855-76 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2021

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