Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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23 October 2023 |
Main ID: |
EUCTR2014-003855-76-NL |
Date of registration:
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16/04/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease
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Scientific title:
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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:
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03/09/2015 |
Target sample size:
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1150 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003855-76 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Extension and safety If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Czechia
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Estonia
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France
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Germany
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Hungary
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Israel
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Italy
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Korea, Republic of
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Latvia
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Lithuania
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Mexico
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Netherlands
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New Zealand
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Poland
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Romania
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Russian Federation
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Serbia
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Key inclusion & exclusion criteria
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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 in either GA29144 or GA29145, period prior to entering
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria: Part 1 Open-label Extension:
-Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
-No exclusion criteria
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Crohn`s Disease MedDRA version: 20.0
Level: PT
Classification code 10011401
Term: Crohn's disease
System Organ Class: 10017947 - Gastrointestinal disorders
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Intervention(s)
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Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105-
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Primary Outcome(s)
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Primary end point(s): The efficacy outcome measures: • CDAI remission assessed at 12-week intervals during Part 1 (OLE) • Clinical remission assessed at 12-week intervals during Part 1 (OLE) • Simplified Endoscopic Index for Crohn’s disease (SES-CD) score assessed at Week 108 or at early withdrawal, if prior to Week 108, during Part 1 (OLE)
Safety Outcome Measures Part 1 (OLE) • Incidence and severity of adverse events • Incidence of serious adverse events • Incidence, rate per subject-year, and severity of infection-related adverse events • Incidence of serious infection-related adverse events • Incidence and severity of injection-site reactions • Incidence of adverse events leading to etrolizumab discontinuation • Incidence of laboratory abnormalities • Incidence and rate per subject-year of malignancies • Incidence of ATAs to etrolizumab • Incidence and severity of hypersensitivity reaction events
Part 2 (SM) • Incidence of suspected or confirmed PML events
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Main Objective: The objectives of this open-label extension-safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety Monitoring; SM) • Progressive multifocal leukoencephalopathy (PML) safety monitoring in patients who have stopped study treatment
Safety Objectives The other safety objectives for this study are as follows: Part 1 (OLE) • To evaluate the incidence, rate per subject-year, and severity of infection-related adverse events • To evaluate the incidence and rate per subject-year of malignancies • To evaluate the incidence and severity of hypersensitivity reactions • To evaluate the incidence and the clinical significance of anti-therapeutic antibodies (ATAs)
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Secondary Objective: Not applicable
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Timepoint(s) of evaluation of this end point: • CDAI remission assessed at 12-week • Clinical remission assessed at 12-week The CDAI and Clinical scores will be calculated, and the APQ (Abdominal Pain Questionnaire) will be completed every 12 weeks and at Study Completion • SES-CD at 108 weeks or at early withdrawal
Safety Outcome Measures (Part 1 and 2) • Weeks, 0, 4, 8, 12 and then every 12 weeks thereafter
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Not applicable
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Secondary end point(s): Not applicable
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Secondary ID(s)
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2014-003855-76-SE
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GA29145
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Source(s) of Monetary Support
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F. Hoffmann-La Roche Ltd
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Ethics review
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Status: Approved
Approval date: 03/09/2015
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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