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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

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ClinicalTrials.gov Identifier: NCT02403323
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE March 31, 2015
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE June 8, 2015
Estimated Primary Completion Date April 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02403323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE Drug: etrolizumab
105 mg etrolizumab subcutaneous administration every 4 weeks
Study Arms  ICMJE
  • Experimental: Part 1 Open-label Extension
    Intervention: Drug: etrolizumab
  • No Intervention: Part 2 Safety Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2015)
900
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2015)
1250
Estimated Study Completion Date  ICMJE April 19, 2024
Estimated Primary Completion Date April 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02403323
Other Study ID Numbers  ICMJE GA29145
2014-003855-76 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP