Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
NCT ID: NCT01461317
Last Updated: 2020-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2011-11-29
2016-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Etrolizumab
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
Etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.
Interventions
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Etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.
Eligibility Criteria
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Inclusion Criteria
* Participants who have not obtained a clinical response in the Phase II study (ABS4986g) by Week 10 (the end of the Phase II treatment phase) may enter this OLE trial at any time after Week 10 and up to and including Week 28
* Participants who have a clinical response in the Phase II study (ABS4986g) at Week 10 but have had a flare of UC between Week 10 and Week 28
* Males and females with reproductive potential must be willing to use a highly effective method of contraception, vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half-lives)
* Concomitant immunosuppressive therapy must be tapered within 6 weeks after enrollment in this OLE study
* Participants must have tapered completely off oral corticosteroids within 24 weeks of enrollment to this OLE study
Exclusion Criteria
* Pregnancy or lactation
* Any new malignancy within the past 6 months
* Any new (since enrolling in the Phase II study \[ABS4986g\]), significant, uncontrolled, co- morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
* Any new clinically significant signs or symptoms of infection as judged by the investigator
* Any abnormal laboratory values recorded at the last visit completed in the Phase II study (ABS4986g)
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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University of California, San Diego
La Jolla, California, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Long Island Clin Rsch Asc, LLP
Great Neck, New York, United States
Consultants for Clin. Rsrch
Cincinnati, Ohio, United States
The Canberra Hospital
Garran, Australian Capital Territory, Australia
St Vincent's Hospital Melbourne; Department of Gastroenterology
Fitzroy, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital; Gastroenterology
Parkville, Victoria, Australia
Imeldaziekenhuis
Bonheiden, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
GI Research Institute
Vancouver, British Columbia, Canada
London Health Sciences Centre; Victoria Hospital
London, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Toronto Digest. Disease Asso.
Woodbridge, Ontario, Canada
Poliklinika Iii, Hk; Hepatogatroenterolgy
Hradec Králové, , Czechia
Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
Náchod, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Krajska nemocnice Tomase Bati
Zlín, , Czechia
CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
Berlin, , Germany
Med. Hochschule Hannover; Gastroenterologie
Hanover, , Germany
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
Kiel, , Germany
Facharzt für Gastroenterologie
Minden, , Germany
Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
Ulm, , Germany
ENDOMEDIX Kft; Gasztroenterológia Budapest
Budapest, , Hungary
Pannónia Klinika Magánorvosi
Budapest, , Hungary
Petz Aladar County Hosp; 1St Dept. of Internal Med.
Győr, , Hungary
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Shaare Zedek Medical Ctr; Dept. of Gastroenterology
Jerusalem, , Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
Tel Aviv, , Israel
Middlemore Hospital
Auckland, , New Zealand
University of Otago, Christchurch
Christchurch, , New Zealand
Dunedin Hospital; Otago District Health Board
Dunedin, , New Zealand
Shakespeare Specialist Group
Takapuna, , New Zealand
Hospital Clinic I Provincial
Barcelona, , Spain
St. Mark's Hospital; Inflammatory Bowel Disease Unit
Harrow, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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2011-003409-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA27927
Identifier Type: -
Identifier Source: org_study_id
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