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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16 October 2023 |
Main ID: |
EUCTR2013-004435-72-CZ |
Date of registration:
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21/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies
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Scientific title:
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AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood |
Date of first enrolment:
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02/10/2014 |
Target sample size:
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2100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004435-72 |
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: Open-label extension and safety monitoring study If controlled, specify comparator, Other Medicinial Product: Placebo: Other: 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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Colombia
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Croatia
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Czech Republic
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Czechia
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Denmark
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Estonia
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France
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Germany
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Greece
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Hong Kong
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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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Malaysia
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Mexico
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Netherlands
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New Zealand
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Norway
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Philippines
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Singapore
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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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Viet Nam
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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 Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol Part 2 (Safety Monitoring) - Patients who participated in one of the etrolizumab Phase II OLE study or Phase III studies and are not eligible or chose not to enter Part 1 (OLE) - Patients who transfer from Part 1 (OLE) - Completion of the 12-week safety follow-up 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 1907 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 193
Exclusion criteria: Part 1 (Open-label Extension) - Any new, significant, uncontrolled condition - Receipt of the following since commencement of the Phase II OLE or Phase III controlled studies: Use of anti-adhesion molecules 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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Ulcerative colitis MedDRA version: 20.1
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
System Organ Class: 100000004856
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Intervention(s)
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Product Name: etrolizumab Product Code: Ro 549-0261/F04 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: rhuMAb Beta7, Anti Beta7, PRO145223 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): 1) Long-term efficacy as determined by partial Mayo Clinic Score (pMCS) 2) To evaluate remission by MCS at Week 108 in Part 1 (OLE) 3) To evaluate endoscopic remission by MCS at Week 108 in Part 1 (OLE) 4) Incidence of adverse events
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Main Objective: • Part 1 (OLE): to assess the long-term safety and efficacy of etrolizumab in eligible patients. • Part 2 (SM): Progressive multifocal leukoencephalopathy (PML) safety monitoring.
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Secondary Objective: n.a.
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Timepoint(s) of evaluation of this end point: For 1 and 4: Up to 7 years 2 and 3: at Week 108 in Part 1 (OLE)
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: n.a.
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Secondary end point(s): n.a.
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Secondary ID(s)
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NCT02118584
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2013-004435-72-GB
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GA28951
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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: 02/10/2014
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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