CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 91 enrolled
Drug / intervention
Tocilizumab +1 moredrug
Likely dose
Tocilizumab 162 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/NCT02682823
NCT02682823Phase 4Completed
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Tocilizumab Real-Life Human Factors Validation Study

Hoffmann-La Roche·interventional·Posted Feb 15, 2016·Updated Apr 19, 2019

In Brief

A Phase 4 clinical trial evaluating AI-1000 G2 and Tocilizumab for Rheumatoid Arthritis. Completed, enrolled 91 participants across 8 sites.

Detailed Summary

This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 15, 2016
Enrollment StartMar 21, 2016
Primary CompletionJul 29, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.4 years ago

Interventions

AI-1000 G2device

Tocilizumab will be administered using the AI-1000 G2.

Tocilizumabdrug

Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.