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 : February 10, 2020
|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)|
|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 29, 2011|
|Actual Primary Completion Date :||August 7, 2016|
|Actual Study Completion Date :||August 7, 2016|
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
Participants will receive etrolizumab at a dose of 100 mg.
- 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]) ]
- 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) ]
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
|Study Director:||Clinical Trials||Genentech, Inc.|