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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 : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Etrolizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 8, 2015
Estimated Primary Completion Date : May 21, 2026
Estimated Study Completion Date : May 21, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).
 Drug: Etrolizumab
105 mg etrolizumab subcutaneous administration once every 4 weeks
Other Name: RG7413
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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.

  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. 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) ]
  14. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403323


Contacts
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Contact: Reference Study ID Number: GA29145 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02403323    
Other Study ID Numbers: GA29145
2014-003855-76 ( EudraCT Number )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Etrolizumab
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs