Last updated on March 2019

A Study to Assess Whether Etrolizumab is a Safe and Effective Treatment for Participants With Moderately to Severely Active Crohn's Disease (CD)


Brief description of study

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be nave to anti-TNFs. The study period will consist of Screening Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease of 70 points in Crohn's Disease Activity Index (CDAI) from baseline (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

Clinical Study Identifier: NCT02394028

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Reference Study ID Number: GA29144 ...

Footscray Hospital; Gastroenterology
Footscray, Australia
1.68miles
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Reference Study ID Number: GA29144 ...

Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
Parkville, Australia
1.71miles
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Reference Study ID Number: GA29144 ...

St Vincent's Hospital Melbourne
Fitzroy, Australia
3.01miles
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Reference Study ID Number: GA29144 ...

Alfred Hospital
Melbourne, Australia
3.3miles
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Reference Study ID Number: GA29144 ...

St Frances Xavier Cabrini Hospital
Malvern, Australia
6.84miles
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Reference Study ID Number: GA29144 ...

Emeritus Research
Malvern East, Australia
8.72miles
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Reference Study ID Number: GA29144 ...

Austin Hospital
Heidelberg, Australia
8.72miles
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Recruitment Status: Open


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