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

This study is currently recruiting participants.

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Contacts and Locations

Verified March 2017 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT02403323

First received: March 26, 2015

Last updated: March 15, 2017

Last verified: March 2017

History of Changes

Purpose

This two-part, open-label extension and safety monitoring study will examine the safety and efficacy of continued etrolizumab treatment in patients with moderate to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.

Condition	Intervention	Phase
Crohn Disease	Drug: etrolizumab	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: No masking 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 ]


Estimated Enrollment:	900
Actual Study Start Date:	June 30, 2015
Estimated Study Completion Date:	May 31, 2024
Estimated Primary Completion Date:	May 31, 2024 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part 1 Open-label Extension	Drug: etrolizumab 105 mg etrolizumab subcutaneous administration every 4 weeks
No Intervention: Part 2 Safety Monitoring

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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 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 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02403323

Contacts


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

Show 425 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02403323 History of Changes
Other Study ID Numbers:	GA29145 2014-003855-76 ( EudraCT Number )
Study First Received:	March 26, 2015
Last Updated:	March 15, 2017

Additional relevant MeSH terms:


Crohn Disease Inflammatory Bowel Diseases Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases

ClinicalTrials.gov processed this record on June 26, 2017

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