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Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Autoimmune Disorder Crohn's Disease
Basic Details
Study 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.
Eligibility 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
Part 1 Open-Label Extension:
- Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
- No exclusion criteria
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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Study results
LPS GA29145 JUNIPER Final Results March 2024 English
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Austria German
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Belgium Dutch
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Bulgarian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Canada French
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Croatian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Czech
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Estonian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 French
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 German
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Hebrew
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Hungarian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Italian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Korean
(PDF, 0.6 MB)
LPS GA29145 JUNIPER Final Results March 2024 LATAM Spanish
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Latvian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Lithuanian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Netherlands Dutch
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Polish
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Portuguese
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Romanian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Russian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Serbian
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Slovak
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Spain Spanish
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Switzerland German
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Turkish
(PDF, 0.5 MB)
LPS GA29145 JUNIPER Final Results March 2024 Ukrainian
(PDF, 0.5 MB)
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For the latest version of this information please go to www.forpatients.roche.com