CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Prefilled Syringe delivery of Golimumab +1 moredrug
Likely dose
Prefilled Syringe delivery of Golimumab 50 mgfrom 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/NCT02155335
NCT02155335Phase 4Completed

Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis

Merck Sharp & Dohme LLC·interventional·Posted Jun 4, 2014·Updated Mar 15, 2019

In Brief

A Phase 4 clinical trial evaluating Prefilled Syringe delivery of Golimumab and Smartject Device delivery of Golimumab for Ulcerative Colitis. Completed, enrolled 100 participants.

Detailed Summary

This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 4, 2014
Enrollment StartJul 1, 2014
Primary CompletionOct 5, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.1 years ago

Interventions

Prefilled Syringe delivery of Golimumabdrug

Golimumab 50 mg solution for subcutaneous injection using prefilled syringe

Smartject Device delivery of Golimumabdrug

Golimumab 50 mg solution for subcutaneous injection using Smartject Device.