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

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ClinicalTrials.gov Identifier: NCT01461317
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrolizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
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
Actual Study Start Date : November 30, 2011
Actual Primary Completion Date : August 8, 2016
Actual Study Completion Date : August 8, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately Week 246 ]
  2. 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 :
  1. 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) ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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)

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


  Show 42 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01461317     History of Changes
Other Study ID Numbers: GA27927
2011-003409-36 ( EudraCT Number )
First Posted: October 28, 2011    Key Record Dates
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