Multiple Sclerosis Clinical Trial

Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis

Summary

This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

All participants (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following 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:

Participants who did not complete through Week 10 of the Phase II study (ABS4986g)
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)

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

121

Study ID:

NCT01461317

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 37 Locations for this study

See Locations Near You

University of California, San Diego
La Jolla California, 92037, United States
Atlanta Gastroenterology Associates
Atlanta Georgia, 30342, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Long Island Clin Rsch Asc, LLP
Great Neck New York, 11021, United States
Consultants for Clin. Rsrch
Cincinnati Ohio, 45219, United States
The Canberra Hospital
Garran Australian Capital Territory, 2065, Australia
St Vincent's Hospital Melbourne; Department of Gastroenterology
Fitzroy Victoria, 3065, Australia
Alfred Hospital
Melbourne Victoria, 3004, Australia
Royal Melbourne Hospital; Gastroenterology
Parkville Victoria, 3050, Australia
Imeldaziekenhuis
Bonheiden , 2820, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
GI Research Institute
Vancouver British Columbia, V6Z 2, Canada
London Health Sciences Centre; Victoria Hospital
London Ontario, N6A 4, Canada
London Health Sciences Centre
London Ontario, N6A 4, Canada
Toronto Digest. Disease Asso.
Woodbridge Ontario, L4L 4, Canada
Poliklinika Iii, Hk; Hepatogatroenterolgy
Hradec Kralove , 500 1, Czechia
Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
Nachod , 547 6, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba , 708 5, Czechia
Krajska nemocnice Tomase Bati
Zlin , 762 7, Czechia
CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
Berlin , 13353, Germany
Med. Hochschule Hannover; Gastroenterologie
Hannover , 30625, Germany
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
Kiel , 24105, Germany
Facharzt für Gastroenterologie
Minden , 32423, Germany
Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
Ulm , 89081, Germany
ENDOMEDIX Kft; Gasztroenterológia Budapest
Budapest , 1073, Hungary
Pannónia Klinika Magánorvosi
Budapest , 1136, Hungary
Petz Aladar County Hosp; 1St Dept. of Internal Med.
Gyor , 9024, Hungary
Rambam Medical Center
Haifa , 31096, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Shaare Zedek Medical Ctr; Dept. of Gastroenterology
Jerusalem , 91031, Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat-Gan , 52621, Israel
Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
Tel Aviv , 64239, Israel
Middlemore Hospital
Auckland , , New Zealand
University of Otago, Christchurch
Christchurch , 8011, New Zealand
Dunedin Hospital; Otago District Health Board
Dunedin , 9054, New Zealand
Shakespeare Specialist Group
Takapuna , 0620, New Zealand
Hospital Clinic I Provincial
Barcelona , 08036, Spain
St. Mark's Hospital; Inflammatory Bowel Disease Unit
Harrow , HA1 3, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne , NE1 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

121

Study ID:

NCT01461317

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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