Health Condition 1: null- Patients with moderate to severe active Ulcerative Colitis who are naive to TNF Inhibitors. Health Condition 2: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: 150 mg/mL of etrolizumab
: (0.7 mL nominal volume). Etrolizumab is formulated as 150 mg/mL in 20 mM histidine,
0.2 M arginine succinate, and 0.04% polysorbate 20, pH 5.8.
Control Interv
Sponsors
F HoffmannLa Roche Ltd
Roche Products India PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: Part 1 (OLE): Patients who were previously enrolled in the Phase II OLE study or the Phase III controlled studies and meet the eligibility criteria for treatment with open-label etrolizumab For women who are not postmenopausal or surgically sterile or use a highly effective method of contraception For men: agreement to remain abstinent Part 2 (SM): Patients who participated in one of the etrolizumab Phase III study GA29102 and are not eligible or chose not to enroll in Part 1 (OLE) Patients who transfer from Part 1 (OLE) of this protocol Ability and willingness to provide written informed consent and comply with the requirements of Part 2 (SM) of the OLE-SM protocol
Exclusion criteria
Exclusion criteria: Part 1 (OLE) Withdrawal of consent from the Phase II OLE study or any of the Phase III studies Patients who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949,GA29102, and GA29103 Inability to comply with the study protocol, in the opinion of the investigator Pregnancy or lactation Exclusion Due to Safety Reasons Part 2 (SM) No exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy outcome measures for this study isare as follows: To describe the long-term efficacy of etrolizumab (105 mg SC every 4 weeks) by pMCS clinical remission for patients with UC in Part 1 (OLE) To summarize remission by MCS at Week 108 in Part 1 (OLE) To summarize endoscopic remission by MCS at Week 108 in Part 1 (OLE) Timepoint: at Week 108 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Ukraine, United Kingdom, United States of America
Contacts
Public ContactPriyanka Bhattacharya
Roche Products (India) Pvt. Ltd.
Outcome results
None listed