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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT02403323
• Date of registration: 26/03/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 JUNIPER
• Scientific 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
• Date of first enrolment: June 8, 2015
• Target sample size: 900
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02403323
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, 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

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Etrolizumab

Primary Outcome(s)

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 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)]

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)]

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 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: 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: 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 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: 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 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: 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: 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)]

Secondary ID(s)

2014-003855-76

GA29145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors