CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 358 enrolled
Drug / intervention
Adalimumab +3 moredrug
Likely dose
Adalimumab 160 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02163759
NCT02163759Phase 3Completed
CompareCT.gov

Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

Hoffmann-La Roche·interventional·Posted Jun 16, 2014·Updated Jul 23, 2021

In Brief

A Phase 3 clinical trial evaluating Adalimumab, Adalimumab Placebo, and 2 other interventions for Ulcerative Colitis. Completed, enrolled 358 participants across 88 sites in 14 countries.

Detailed Summary

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Brazil, Bulgaria, Estonia, France, Hong Kong, Mexico, Poland, Russia, Serbia, Slovakia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 16, 2014
Enrollment StartNov 4, 2014
Primary CompletionFeb 19, 2020
Study CompletionMar 19, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.0 years ago

Interventions

Adalimumabdrug

Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6, and 8.

Adalimumab Placeboother

Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6, and 8.

Etrolizumabdrug

Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W) up to Week 12 (at Weeks 0 \[Day 1\], 4, 8, and 12 \[clinical remitters only\]).

Etrolizumab Placeboother

Placebo matching to etrolizumab will be administered SC once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 \[Day 1\], 4, 8, and 12 \[clinical remitters only\]).