CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 358 enrolled
Drug / intervention
Adalimumab +3 moredrug
Likely dose
Etrolizumab 105 mg subcutaneously every 4 weeks (at Weeks 0, 4, 8, and 12 for clinical remitters only)AI-extracted
Key inclusion· 4
  • ✓Diagnosis of ulcerative colitis established at least 3 months prior to randomization
  • ✓Moderate to severe ulcerative colitis activity by Mayo Clinic Score
  • ✓Naive to TNF inhibitor therapy
  • ✓Inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
Key exclusion· 15
  • ✕Prior TNF-alpha antagonist therapy
  • ✕Prior etrolizumab or other anti-integrin agent therapy
  • ✕Prior rituximab therapy
  • ✕Tofacitinib use during screening

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

Search/NCT02171429
NCT02171429Phase 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 24, 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 90 sites in 19 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 naIve 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 (GA28948; NCT02163759) was independently conducted.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Brazil, Bulgaria, Colombia, Croatia, Czechia, France, Greece, Hungary, Latvia, Lithuania, Malaysia, New Zealand, Poland, Russia, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 24, 2014
Enrollment StartNov 14, 2014
Primary CompletionMar 2, 2020
Study CompletionMay 25, 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 \[clinical remitters only\]).