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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01461317
First Posted: October 28, 2011
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis Drug: Etrolizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately Week 246 ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [ Time Frame: Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246]) ]

Secondary Outcome Measures:
  • Serum Concentrations of Etrolizumab [ Time Frame: Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246) ]

Enrollment: 121
Actual Study Start Date: November 30, 2011
Study Completion Date: August 8, 2016
Primary Completion Date: August 8, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etrolizumab
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
Drug: Etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461317


  Hide Study Locations
Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Long Island Clin Rsch Asc, LLP
Great Neck, New York, United States, 11021
United States, Ohio
Consultants for Clin. Rsrch
Cincinnati, Ohio, United States, 45219
Australia, Australian Capital Territory
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2065
Australia, Victoria
St Vincent's Hospital Melbourne; Department of Gastroenterology
Fitzroy, Victoria, Australia, 3065
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital; Gastroenterology
Parkville, Victoria, Australia, 3050
Belgium
Imeldaziekenhuis
Bonheiden, Belgium, 2820
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Canada, British Columbia
GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
London Health Sciences Centre; Victoria Hospital
London, Ontario, Canada, N6A 5W9
Toronto Digest. Disease Asso.
Woodbridge, Ontario, Canada, L4L 4Y7
Czech Republic
Poliklinika Iii, Hk; Hepatogatroenterolgy
Hradec Kralove, Czech Republic, 500 12
Oblastni nemocnice Nachod
Nachod, Czech Republic, 547 01
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czech Republic, 708 52
Krajska nemocnice Tomase Bati
Zlin, Czech Republic, 762 75
Germany
CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
Berlin, Germany, 13353
Med. Hochschule Hannover; Gastroenterologie
Hannover, Germany, 30625
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck, Germany, 23538
Facharzt für Gastroenterologie
Minden, Germany, 32423
Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
Ulm, Germany, 89081
Hungary
ENDOMEDIX Kft; Gasztroenterológia Budapest
Budapest, Hungary, 1073
Pannónia Klinika Magánorvosi
Budapest, Hungary, 1136
Petz Aladar County Hosp; 1St Dept. of Internal Med.
Gyor, Hungary, 9024
Israel
Soroka Medical Center; Gastroenterology
Beer Sheva, Israel, 84105
Rambam Medical Center
Haifa, Israel, 31096
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Shaare Zedek Medical Ctr; Dept. of Gastroenterology
Jerusalem, Israel, 91031
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat-Gan, Israel, 52621
Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
Tel Aviv, Israel, 64239
New Zealand
Middlemore Hospital
Auckland, New Zealand
University of Otago, Christchurch
Christchurch, New Zealand, 8011
Dunedin Hospital; Otago District Health Board
Dunedin, New Zealand, 9054
Shakespeare Specialist Group
Takapuna, New Zealand, 0620
Spain
Hospital Clinic I Provincial
Barcelona, Spain, 08036
United Kingdom
St. Mark's Hospital; Inflammatory Bowel Disease Unit
Harrow, United Kingdom, HA1 3UJ
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01461317     History of Changes
Other Study ID Numbers: GA27927
2011-003409-36 ( EudraCT Number )
First Submitted: October 12, 2011
First Posted: October 28, 2011
Last Update Posted: March 15, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases